FAQ

  • All
  • For Institutions
  • For Individuals
  • About iPSCs
  • Other

For Institutions

We perform a wide variety of assays for our research and GMP-grade iPSCs including pluripotency marker expression by flow cytometry and cell-based immunofluorescence assay, karyotyping, microarray analysis, residual vector testing, sterility, endotoxin, mycoplasma testing, etc. We use validated and GMP-appropriate assays performed under a stringent quality management system for our GMP iPSCs. Please inquire for more details. 

Our donor screeningand eligibility is compliant with 21 CFR 1271 and Japanese donor eligibility recommendation

We use Sendai Virus to induce iPSCs

We are licensed by the Japanese Ministry of Health, Labor, and Welfare and audited by the PMDA. USFDA’s cGMP regulations are built into the design of the facility

Yes, we can do custom manufacturing with client-sourced materials (as long as it passes our acceptance criteria) or source donors meeting client-specified criteria. Reach out to us to learn more.

We have 5 lines available at the moment but are continuously expanding our portfolio.

Yes, we have research-grade iPSC lines established from Master Cell Banks of the GMP lines available for testing. Contact us to learn more.

We prefer to work with PBMCs isolated from whole blood with Ficoll. Please discuss with us if you are interested in using other cell types.

For Individual

Currently, clinical research using iPSCs is being conducted by multiple institutions, but it is still not possible to use it immediately. iPSC banking is a service to prepare for when it becomes available in the future.

As you grow older, the DNA in your cells can become damaged. iPSCs made from cells that have less damage are better suited for future therapeutic applications; therefore it is desirable to make and store iPS cells as early as possible. There are several iPSC-derived cell therapies undergoing clinical trial right now. If you have your iPSCs generated and banked already, you may be able to access them as soon as they’re approved.

Regenerative medicine using iPS cells is advancing in a wide range of fields. Check out our blog to learn about the latest research advances.

The iPSCs may only be used for yourself.

Once we receive an application, we will set up a blood collection appointment. We will test for infectious diseases as part of our acceptance criteria and once the test results come back negative, we will start the iPSC generation and storage process.

iPSCs are pluripotent, meaning they can differentiate into any cell type of the body. iPSCs have a clear advantage over other stems cells such as MSCs, HSCs, or dental pulp stem cells due to their pluripotency and ability to be generated from anyone’s cells.

Research is currently underway for iPSC-derived cell therapy for various diseases. If you generate and store your own iPSCs in advance, you will be able to access them as soon as treatments are approved.

Although a cancer gene is used to generate iPSCs, our stringent QC process ensures there are no residual genes in the cells. There is no evidence showing that risk of cancer with iPSCs is increased compared with other cell therapy.

$20,000 USD / ¥2,000,000 plus annual banking fee.

Generally, anyone can bank their iPSCs. Please consult with us if you have any concerns.

Tokyo Toyosu Cancer Clinic (Tokyo), Seta Clinic (Tokyo), and Kajiyama Clinic (Kyoto)

In most cases, you can still generate and bank your iPSCs. Reach out to us.

There is no minimum or maximum age limit for banking iPSCs. Since we perform viral testing for regulatory compliance, we do need 30 mL (about two tablespoons) of blood and recognize that this may be too burdensome for very young children. Reach out to us to discuss your specific situation.

We use a special reagent and method to make sure the cells maintain their viability after freezing

Cryopreservation does not impact quality. In fact, since it takes time to evaluate the quality of a manufactured cell product, iPSCs that are generated, stored, and evaluated for quality prior to being needed makes them easier to use. This means a quicker route to treatment once there is an approved treatment.

We highly encourage informing your primary care doctor about your banked iPSCs. Once there are approved clinical uses for iPSCs, your doctor will reach out to I Peace to facilitate transfer of the stored iPSCs to the institution that will generate the cell therapy product for transplantation.

iPSC-derived cell therapy is a new and quickly growing field. The risk with banking your iPSCs is that there is no guarantee there will be an approved iPSC-derived cell therapy for the disease or treatment you need when you need it. While there have been multiple studies that discuss the potential mutagenicity of iPSCs, subsequent studies have shown no increased risk. Take a look at our blog for more information.

We have highly trained Certified Clinical Cell Product Technicians that have deep expertise in manufacturing iPSCs for clinical use. In addition to experience manufacturing cells in a sterile, clean environment of a GMP facility, our technicians also understand the intricacies of iPSC manufacturing.

About iPSCs

Induced pluripotent stem cells (iPS cells or iPSCs) are stem cells induced from somatic cells that are reprogrammed to an embryonic stem cell-like state by introducing special factors (genes). iPSCs are able to become any type of cells in the body and proliferate almost indefinitely, like an embryonic stem cell. Thus, iPSCs provide for an unlimited source of any type of human cell needed for therapeutic purposes.

Mouse iPSC were first reported in 2006, and human iPSCs were first reported in late 2007.

The iPSC technology was pioneered by a Japanese scientist Shinya Yamanaka, a professor of Kyoto University, Japan. He shared the Nobel Prize in Physiology or Medicine 2012 with Sir John Gurdon for the discovery that cells from adult tissues can be reprogrammed to become pluripotent.

I Peace’s CEO Koji Tanabe is a second author of a paper that reported the successful production of human iPS cells for the first time in the world.

iPSCs are generated from adult somatic cells such as skin or blood cells by introducing reprograming factors (genes) using vectors such as plasmids, RNA or viral vectors. I Peace is manufacturing iPS cells by introducing reprogramming genes in a way that does not damage DNA.

There are two main ways to apply iPSC technology. One is the so-called regenerative medicine, where cells such as neurons and heart cells derived from their own iPSCs, or those from another, are generated and transplanted. If one receives their own iPSC-derived cells one benefits from minimized risk of immune rejection. The other is to use patient-derived iPSCs and convert them into cells specific to their disease and use for research such as drug discovery screening, toxicity testing, and studying the mechanism of disease by reproducing the disease state in vitro.

iPSCs have the following three features:

  1. Potential ability to be generated from any cell type in the body.
    iPSCs can be made by introducing four genetic factors into a variety of cell types such as blood cells, skin cells, or hair cells and then growing those cells until reprogramming is complete. With the current technology, iPSCs can be made with just 5 mL of blood.

  2. Being able to transform into cells of various tissues and organs.
    A major feature of iPSCs is that they have “pluripotency”. Pluripotency means being able to become any cell type, such as neurons or heart muscle cells, etc.

  3. Have the ability to proliferate almost indefinitely
    Since iPSCs can divide and proliferate rapidly, they can be easily cultured and expanded to obtain the needed number of cells.

There are two major categories of stem cells, adult or cord blood stem cells and pluripotent stem cells.

  1. Advantages of iPSCs over these stem cells
    iPSCs are unrivaled as patient-derived stem cells in their ability to differentiate into all tissue and cell types. iPSCs can be made from an individual person of any age from a small blood or skin sample.

    iPSCs also possess the ability to proliferate in cell culture almost indefinitely and are therefore the ultimate source of material for cell based and tissue regeneration therapy.

  2. Mesenchymal Stem Cell
    MSCs can be isolated from cord blood, as well as from bone marrow, placenta, adipose tissue, dental pulp and other organs. They show relatively narrow multipotent differentiation into various cell types both in culture and when transplanted autologously. Their use in cell therapy is however, largely unregulated.
  3. Dental Pulp Stem Cell
    Dental pulp stem cells (DPSCs) are a specific type of mesenchymal stem cells (MSCs) from the inner tooth that show relatively broad multipotent differentiation into various cell types both in culture and when transplanted. they can differentiate in several cell-populations such as odontoblast, osteoblasts, neural cells, chondrocytes, adipocytes, myoblasts, fibroblasts, and endothelial cells. They have greater proliferative capacity than many other MSCs, including those from cord blood, but still limited compared with iPSCs. They have been useful not only for dental diseases, but also for systemic diseases.
  4. Cord Blood Hematopoetic Stem Cells
    Cord blood is normally collected after the baby is delivered and the cord is cut. Cord blood contains blood-forming stem cells that can be used in the treatment of patients with blood cancers such as leukemias and lymphomas, as well as certain disorders of the blood and immune systems, such as sickle cell disease and Wiskott-Aldrich syndrome. There are three major differences between cord blood stem cell and pluripotent stem cells (iPSCs and ESCs). Firstly, cord blood stem cell can differentiate only into blood cells whereas pluripotent stem cells can differentiate into various type of cells. Therefore, cord blood is approved only for use in “hematopoietic stem cell transplantation” procedures. Secondly, cord blood hematopoietic stem cells can only be produced from cells in baby’s cord. Lastly, iPS cells and ES cells can proliferate indefinitely, whereas cord blood hematopoietic stem cells are difficult to be expanded, making it difficult to obtain the amount required for transplantation.

 

There are three major differences between iPSCs and ESCs: The origin of the cells, ethical issues and risks of immune rejection. ESCs are derived from the inner cell mass of a blastocyst‐stage embryo before the soma and the germ cell lineages separate and the embryo is destroyed in the process. In contrast, iPSCs are derived from easily isolated somatic cells, without harm to the donor. Thus, the iPSC production method does not require the destruction of an embryo. It avoids the ethical issues that surround the use of human ES cells. Furthermore, unlike human ES cells, it is possible to generate donor-specific iPS cells and convert them into various types of cells, which can be transplanted back into the patient with minimized risk of immune rejection.

Yes, iPSCs can be made from people of any age.

Theoretically, iPS cells are capable of differentiating into cells of all types of organs including nervous system, cardiac muscle, and blood. However, organs are more complex because of their three-dimensional (3D) tissue structure. Therefore, it is not easy to form functional three dimensional-organs from pluripotent stem cells. Formation of small livers have been reported, but there are as yet no reports of large 3D, functional organs of human size. This is an area that requires further development by combining iPS cell technologies, more sophisticated use of 3D printers, biomaterials, and other technologies. At this moment, research on the formation and the application of cell sheets will precede generation of iPSC-derived functional three-dimensional organs. In January 2020, Osaka University in Japan announced that they had conducted the world’s first clinical trial for transplanting iPS cell-derived cardiac sheets onto a patient’s heart with severe failure.

Clinical research on the diseases listed below has already begun. However,
Research on diseases other than those listed below has also been studied.

AMD (Age-related macular degeneration), Corneal disease, Retinitis Pigmentosa, Spinal Cord Injury, Graft versus host disease, Muscular Dystrophy, Diabetes, Parkinsons Disease, Pendred Syndrome, Heart Disease, CAR-T Cell Therapy, NK Cell Cancer, Hematologic Malignancies
Blood Transfusion/aplastic anemia.

<Advantages>

  1. Issues of histocompatibility with donor/recipient transplants can be avoided iPSCs can be generated from the patient’s own cells so that iPS-derivedcell transplantation with minimal risk of immune rejection is possible.

  2. Ethical Issue can be avoided The advantage of iPSCs is that they are not derived from human embryos, which is the ethical concern in this field. By removing the bioethical issues, the scientists are likely to be able to obtain more federal funding and support. Moreover, patient who bank their own clinical-grade iPSCs are primed to take advantage of any newly emerging cell-based therapy.

  3. Useful for drug development and disease mechanism studies iPSCs are useful tool for disease modeling. Cells such as neurons and cardiomyocytes made from iPSCs derived from patient’s blood, etc., can have the same phenotype as the patients’ cells in the body. Cells with the characteristics of the disease can thus be cultured on a culture dish to observe the disease state. In other words, you can reproduce the disease state in vitro and observe the nature and mechanism of the disease. In addition, it is possible to confirm the effect and toxicity of drugs in vitro by applying various compounds, such as drug candidates, to the cells. Another significant benefit of iPS cell technology would permit for creation of isogenic control cell lines using CRISPR/Cas9 gene editing that are genetically tailored to model a disease phenotype.

With numerous advantages as mentioned above, we don’t see any disadvantage in iPSC.

 

Disease-specific iPSCs are useful for drug discovery.
iPSCs derived from patients with a variety of diseases. Disease-specific iPSCs offer an opportunity to recapitulate both normal and pathologic human tissue formation in vitro. They can have the same phenotype as the patients’ cells in the body. Cells with the characteristics of the disease can thus be cultured on a culture dish to study the nature and treatment of the disease state. In addition, it is possible to confirm the effect and toxicity of drugs in vitro by applying various compounds, such as drug candidates, to the cells.

The overarching issue for application of iPSCs in personalized medicine is that it must become possible to have clinic-ready patient-derived iPSC lines available to all aspects of stem cell research and clinical application. Our approach using robotics and a closed, miniaturized fluidic system will allow for mass parallel derivation within a GMP facility. This means that our iPSCs products will be available not only to patients when needed, but also to researchers striving to understand the basis of disease at the cell and molecular level, with fidelity of the individual cell genotype (genome sequence) and disease phenotype (for example, how a drug influences disease progression in an individual’s cells).

The overarching issue for application of iPSCs in personalized medicine is that it must become possible to have clinic-ready patient-derived iPSC lines available to all aspects of stem cell research and clinical application. Our approach using robotics and a closed, miniaturized fluidic system will allow for mass parallel derivation within a GMP facility. This means that our iPSCs products will be available to patients when needed, but also to researchers striving to understand the basis of disease at the cell and molecular level, with fidelity of the individual cell genotype (genome sequence) and disease phenotype (for example, how a drug influences disease progression in an individual cells).

iPSCs have already been used for drug screenings and its use is expected to expand rapidly.
In regenerative medicine, since Professor Shinya Yamanaka announced the successful generation of human iPSCs in 2007, various studies have been conducted for clinical applications in Japan, US and in many other countries. Examples of diseases for which clinical research has already begun include age-related macular degeneration, Parkinson’s disease, severe ischemic cardiomyopathy, and spinal cord injury. In addition, research is being conducted on application to diabetes, corneal disease, cerebral infarction, and liver and kidney diseases, among many others.
Also, CAR-T cell therapy research is attracting attention as one example of cancer treatment using iPSCs. This is an immunotherapy in which a patient’s blood-derived iPSCs are genetically modified to produce T immune cells that can recognize and attack specific cancer cells when returned to the patient’s body.

Not for the moment, but we are hoping that iPS cells will eventually be able to replace most, if not all, of the need for organ transplant. For this end, it’s important that autologous (obtained from oneself) iPS cell banking gains public support and demand. To achieve this, we continue our efforts to further reduce the cost of iPS cells production.

It seems that no company other than I Peace has succeeded in developing a fully closed system iPS cell automatic production system.

The key element is that it enables miniaturized and robotic mass production of clinical-grade iPS cells from a large number of donors simultaneously in a single room.

Manufacturing cost (NOT selling price) of clinical-grade iPSCs has been more than $1,000,000. I Peace, Inc has succeeded in lowering the direct manufacturing cost to several tens of thousand dollars.

Currently, there are very few iPSC provider worldwide that can manufacture clinical grade iPSCs on a contract basis. We support clinical research using iPS cells by simultaneously providing multiple clinical-grade iPS cell lines. We can and will provide large quantities of research grade iPS cells to institutions who conducts drug screenings.

He has been involved in iPSC research since the beginning of iPSC development, and is the second author of a paper reporting the successful establishment of human iPS cells for the first time in the world. He researched the mechanism of reprogramming for 7 years at Dr. Shinya Yamanaka’s lab. As a postdoctoral researcher at Stanford University in the laboratory of Dr. Marius Werning who succeeded in the direct reprogramming from skin cells to neurons for the first time in the world, his work focused on the mechanism of direct reprogramming from blood cells to neurons and iPSC reprogramming. He has contributed to numerous papers on both iPSCs and the direct reprogramming into neurons.

We perform a wide variety of assays for our research and GMP-grade iPSCs including pluripotency marker expression by flow cytometry and cell-based immunofluorescence assay, karyotyping, microarray analysis, residual vector testing, sterility, endotoxin, mycoplasma testing, etc. We use validated and GMP-appropriate assays performed under a stringent quality management system for our GMP iPSCs. Please inquire for more details. 

Our donor screeningand eligibility is compliant with 21 CFR 1271 and Japanese donor eligibility recommendation

We use Sendai Virus to induce iPSCs

We are licensed by the Japanese Ministry of Health, Labor, and Welfare and audited by the PMDA. USFDA’s cGMP regulations are built into the design of the facility

Yes, we can do custom manufacturing with client-sourced materials (as long as it passes our acceptance criteria) or source donors meeting client-specified criteria. Reach out to us to learn more.

We have 5 lines available at the moment but are continuously expanding our portfolio.

Yes, we have research-grade iPSC lines established from Master Cell Banks of the GMP lines available for testing. Contact us to learn more.

We prefer to work with PBMCs isolated from whole blood with Ficoll. Please discuss with us if you are interested in using other cell types.

Currently, clinical research using iPSCs is being conducted by multiple institutions, but it is still not possible to use it immediately. iPSC banking is a service to prepare for when it becomes available in the future.

As you grow older, the DNA in your cells can become damaged. iPSCs made from cells that have less damage are better suited for future therapeutic applications; therefore it is desirable to make and store iPS cells as early as possible. There are several iPSC-derived cell therapies undergoing clinical trial right now. If you have your iPSCs generated and banked already, you may be able to access them as soon as they’re approved.

Regenerative medicine using iPS cells is advancing in a wide range of fields. Check out our blog to learn about the latest research advances.

The iPSCs may only be used for yourself.

Once we receive an application, we will set up a blood collection appointment. We will test for infectious diseases as part of our acceptance criteria and once the test results come back negative, we will start the iPSC generation and storage process.

iPSCs are pluripotent, meaning they can differentiate into any cell type of the body. iPSCs have a clear advantage over other stems cells such as MSCs, HSCs, or dental pulp stem cells due to their pluripotency and ability to be generated from anyone’s cells.

Research is currently underway for iPSC-derived cell therapy for various diseases. If you generate and store your own iPSCs in advance, you will be able to access them as soon as treatments are approved.

Although a cancer gene is used to generate iPSCs, our stringent QC process ensures there are no residual genes in the cells. There is no evidence showing that risk of cancer with iPSCs is increased compared with other cell therapy.

$20,000 USD / ¥2,000,000 plus annual banking fee.

Generally, anyone can bank their iPSCs. Please consult with us if you have any concerns.

Tokyo Toyosu Cancer Clinic (Tokyo), Seta Clinic (Tokyo), and Kajiyama Clinic (Kyoto)

In most cases, you can still generate and bank your iPSCs. Reach out to us.

There is no minimum or maximum age limit for banking iPSCs. Since we perform viral testing for regulatory compliance, we do need 30 mL (about two tablespoons) of blood and recognize that this may be too burdensome for very young children. Reach out to us to discuss your specific situation.

We use a special reagent and method to make sure the cells maintain their viability after freezing

Cryopreservation does not impact quality. In fact, since it takes time to evaluate the quality of a manufactured cell product, iPSCs that are generated, stored, and evaluated for quality prior to being needed makes them easier to use. This means a quicker route to treatment once there is an approved treatment.

We highly encourage informing your primary care doctor about your banked iPSCs. Once there are approved clinical uses for iPSCs, your doctor will reach out to I Peace to facilitate transfer of the stored iPSCs to the institution that will generate the cell therapy product for transplantation.

iPSC-derived cell therapy is a new and quickly growing field. The risk with banking your iPSCs is that there is no guarantee there will be an approved iPSC-derived cell therapy for the disease or treatment you need when you need it. While there have been multiple studies that discuss the potential mutagenicity of iPSCs, subsequent studies have shown no increased risk. Take a look at our blog for more information.

We have highly trained Certified Clinical Cell Product Technicians that have deep expertise in manufacturing iPSCs for clinical use. In addition to experience manufacturing cells in a sterile, clean environment of a GMP facility, our technicians also understand the intricacies of iPSC manufacturing.

Induced pluripotent stem cells (iPS cells or iPSCs) are stem cells induced from somatic cells that are reprogrammed to an embryonic stem cell-like state by introducing special factors (genes). iPSCs are able to become any type of cells in the body and proliferate almost indefinitely, like an embryonic stem cell. Thus, iPSCs provide for an unlimited source of any type of human cell needed for therapeutic purposes.

Mouse iPSC were first reported in 2006, and human iPSCs were first reported in late 2007.

The iPSC technology was pioneered by a Japanese scientist Shinya Yamanaka, a professor of Kyoto University, Japan. He shared the Nobel Prize in Physiology or Medicine 2012 with Sir John Gurdon for the discovery that cells from adult tissues can be reprogrammed to become pluripotent.

I Peace’s CEO Koji Tanabe is a second author of a paper that reported the successful production of human iPS cells for the first time in the world.

iPSCs are generated from adult somatic cells such as skin or blood cells by introducing reprograming factors (genes) using vectors such as plasmids, RNA or viral vectors. I Peace is manufacturing iPS cells by introducing reprogramming genes in a way that does not damage DNA.

There are two main ways to apply iPSC technology. One is the so-called regenerative medicine, where cells such as neurons and heart cells derived from their own iPSCs, or those from another, are generated and transplanted. If one receives their own iPSC-derived cells one benefits from minimized risk of immune rejection. The other is to use patient-derived iPSCs and convert them into cells specific to their disease and use for research such as drug discovery screening, toxicity testing, and studying the mechanism of disease by reproducing the disease state in vitro.

iPSCs have the following three features:

  1. Potential ability to be generated from any cell type in the body.
    iPSCs can be made by introducing four genetic factors into a variety of cell types such as blood cells, skin cells, or hair cells and then growing those cells until reprogramming is complete. With the current technology, iPSCs can be made with just 5 mL of blood.

  2. Being able to transform into cells of various tissues and organs.
    A major feature of iPSCs is that they have “pluripotency”. Pluripotency means being able to become any cell type, such as neurons or heart muscle cells, etc.

  3. Have the ability to proliferate almost indefinitely
    Since iPSCs can divide and proliferate rapidly, they can be easily cultured and expanded to obtain the needed number of cells.

There are two major categories of stem cells, adult or cord blood stem cells and pluripotent stem cells.

  1. Advantages of iPSCs over these stem cells
    iPSCs are unrivaled as patient-derived stem cells in their ability to differentiate into all tissue and cell types. iPSCs can be made from an individual person of any age from a small blood or skin sample.

    iPSCs also possess the ability to proliferate in cell culture almost indefinitely and are therefore the ultimate source of material for cell based and tissue regeneration therapy.

  2. Mesenchymal Stem Cell
    MSCs can be isolated from cord blood, as well as from bone marrow, placenta, adipose tissue, dental pulp and other organs. They show relatively narrow multipotent differentiation into various cell types both in culture and when transplanted autologously. Their use in cell therapy is however, largely unregulated.
  3. Dental Pulp Stem Cell
    Dental pulp stem cells (DPSCs) are a specific type of mesenchymal stem cells (MSCs) from the inner tooth that show relatively broad multipotent differentiation into various cell types both in culture and when transplanted. they can differentiate in several cell-populations such as odontoblast, osteoblasts, neural cells, chondrocytes, adipocytes, myoblasts, fibroblasts, and endothelial cells. They have greater proliferative capacity than many other MSCs, including those from cord blood, but still limited compared with iPSCs. They have been useful not only for dental diseases, but also for systemic diseases.
  4. Cord Blood Hematopoetic Stem Cells
    Cord blood is normally collected after the baby is delivered and the cord is cut. Cord blood contains blood-forming stem cells that can be used in the treatment of patients with blood cancers such as leukemias and lymphomas, as well as certain disorders of the blood and immune systems, such as sickle cell disease and Wiskott-Aldrich syndrome. There are three major differences between cord blood stem cell and pluripotent stem cells (iPSCs and ESCs). Firstly, cord blood stem cell can differentiate only into blood cells whereas pluripotent stem cells can differentiate into various type of cells. Therefore, cord blood is approved only for use in “hematopoietic stem cell transplantation” procedures. Secondly, cord blood hematopoietic stem cells can only be produced from cells in baby’s cord. Lastly, iPS cells and ES cells can proliferate indefinitely, whereas cord blood hematopoietic stem cells are difficult to be expanded, making it difficult to obtain the amount required for transplantation.

 

There are three major differences between iPSCs and ESCs: The origin of the cells, ethical issues and risks of immune rejection. ESCs are derived from the inner cell mass of a blastocyst‐stage embryo before the soma and the germ cell lineages separate and the embryo is destroyed in the process. In contrast, iPSCs are derived from easily isolated somatic cells, without harm to the donor. Thus, the iPSC production method does not require the destruction of an embryo. It avoids the ethical issues that surround the use of human ES cells. Furthermore, unlike human ES cells, it is possible to generate donor-specific iPS cells and convert them into various types of cells, which can be transplanted back into the patient with minimized risk of immune rejection.

Yes, iPSCs can be made from people of any age.

Theoretically, iPS cells are capable of differentiating into cells of all types of organs including nervous system, cardiac muscle, and blood. However, organs are more complex because of their three-dimensional (3D) tissue structure. Therefore, it is not easy to form functional three dimensional-organs from pluripotent stem cells. Formation of small livers have been reported, but there are as yet no reports of large 3D, functional organs of human size. This is an area that requires further development by combining iPS cell technologies, more sophisticated use of 3D printers, biomaterials, and other technologies. At this moment, research on the formation and the application of cell sheets will precede generation of iPSC-derived functional three-dimensional organs. In January 2020, Osaka University in Japan announced that they had conducted the world’s first clinical trial for transplanting iPS cell-derived cardiac sheets onto a patient’s heart with severe failure.

Clinical research on the diseases listed below has already begun. However,
Research on diseases other than those listed below has also been studied.

AMD (Age-related macular degeneration), Corneal disease, Retinitis Pigmentosa, Spinal Cord Injury, Graft versus host disease, Muscular Dystrophy, Diabetes, Parkinsons Disease, Pendred Syndrome, Heart Disease, CAR-T Cell Therapy, NK Cell Cancer, Hematologic Malignancies
Blood Transfusion/aplastic anemia.

<Advantages>

  1. Issues of histocompatibility with donor/recipient transplants can be avoided iPSCs can be generated from the patient’s own cells so that iPS-derivedcell transplantation with minimal risk of immune rejection is possible.

  2. Ethical Issue can be avoided The advantage of iPSCs is that they are not derived from human embryos, which is the ethical concern in this field. By removing the bioethical issues, the scientists are likely to be able to obtain more federal funding and support. Moreover, patient who bank their own clinical-grade iPSCs are primed to take advantage of any newly emerging cell-based therapy.

  3. Useful for drug development and disease mechanism studies iPSCs are useful tool for disease modeling. Cells such as neurons and cardiomyocytes made from iPSCs derived from patient’s blood, etc., can have the same phenotype as the patients’ cells in the body. Cells with the characteristics of the disease can thus be cultured on a culture dish to observe the disease state. In other words, you can reproduce the disease state in vitro and observe the nature and mechanism of the disease. In addition, it is possible to confirm the effect and toxicity of drugs in vitro by applying various compounds, such as drug candidates, to the cells. Another significant benefit of iPS cell technology would permit for creation of isogenic control cell lines using CRISPR/Cas9 gene editing that are genetically tailored to model a disease phenotype.

With numerous advantages as mentioned above, we don’t see any disadvantage in iPSC.

 

Disease-specific iPSCs are useful for drug discovery.
iPSCs derived from patients with a variety of diseases. Disease-specific iPSCs offer an opportunity to recapitulate both normal and pathologic human tissue formation in vitro. They can have the same phenotype as the patients’ cells in the body. Cells with the characteristics of the disease can thus be cultured on a culture dish to study the nature and treatment of the disease state. In addition, it is possible to confirm the effect and toxicity of drugs in vitro by applying various compounds, such as drug candidates, to the cells.

The overarching issue for application of iPSCs in personalized medicine is that it must become possible to have clinic-ready patient-derived iPSC lines available to all aspects of stem cell research and clinical application. Our approach using robotics and a closed, miniaturized fluidic system will allow for mass parallel derivation within a GMP facility. This means that our iPSCs products will be available not only to patients when needed, but also to researchers striving to understand the basis of disease at the cell and molecular level, with fidelity of the individual cell genotype (genome sequence) and disease phenotype (for example, how a drug influences disease progression in an individual’s cells).

The overarching issue for application of iPSCs in personalized medicine is that it must become possible to have clinic-ready patient-derived iPSC lines available to all aspects of stem cell research and clinical application. Our approach using robotics and a closed, miniaturized fluidic system will allow for mass parallel derivation within a GMP facility. This means that our iPSCs products will be available to patients when needed, but also to researchers striving to understand the basis of disease at the cell and molecular level, with fidelity of the individual cell genotype (genome sequence) and disease phenotype (for example, how a drug influences disease progression in an individual cells).

iPSCs have already been used for drug screenings and its use is expected to expand rapidly.
In regenerative medicine, since Professor Shinya Yamanaka announced the successful generation of human iPSCs in 2007, various studies have been conducted for clinical applications in Japan, US and in many other countries. Examples of diseases for which clinical research has already begun include age-related macular degeneration, Parkinson’s disease, severe ischemic cardiomyopathy, and spinal cord injury. In addition, research is being conducted on application to diabetes, corneal disease, cerebral infarction, and liver and kidney diseases, among many others.
Also, CAR-T cell therapy research is attracting attention as one example of cancer treatment using iPSCs. This is an immunotherapy in which a patient’s blood-derived iPSCs are genetically modified to produce T immune cells that can recognize and attack specific cancer cells when returned to the patient’s body.

Not for the moment, but we are hoping that iPS cells will eventually be able to replace most, if not all, of the need for organ transplant. For this end, it’s important that autologous (obtained from oneself) iPS cell banking gains public support and demand. To achieve this, we continue our efforts to further reduce the cost of iPS cells production.

It seems that no company other than I Peace has succeeded in developing a fully closed system iPS cell automatic production system.

The key element is that it enables miniaturized and robotic mass production of clinical-grade iPS cells from a large number of donors simultaneously in a single room.

Manufacturing cost (NOT selling price) of clinical-grade iPSCs has been more than $1,000,000. I Peace, Inc has succeeded in lowering the direct manufacturing cost to several tens of thousand dollars.

Currently, there are very few iPSC provider worldwide that can manufacture clinical grade iPSCs on a contract basis. We support clinical research using iPS cells by simultaneously providing multiple clinical-grade iPS cell lines. We can and will provide large quantities of research grade iPS cells to institutions who conducts drug screenings.

He has been involved in iPSC research since the beginning of iPSC development, and is the second author of a paper reporting the successful establishment of human iPS cells for the first time in the world. He researched the mechanism of reprogramming for 7 years at Dr. Shinya Yamanaka’s lab. As a postdoctoral researcher at Stanford University in the laboratory of Dr. Marius Werning who succeeded in the direct reprogramming from skin cells to neurons for the first time in the world, his work focused on the mechanism of direct reprogramming from blood cells to neurons and iPSC reprogramming. He has contributed to numerous papers on both iPSCs and the direct reprogramming into neurons.

  • All
  • For Institutions
  • For Individuals
  • About iPSCs
  • Other

For Institutions

We perform a wide variety of assays for our research and GMP-grade iPSCs including pluripotency marker expression by flow cytometry and cell-based immunofluorescence assay, karyotyping, microarray analysis, residual vector testing, sterility, endotoxin, mycoplasma testing, etc. We use validated and GMP-appropriate assays performed under a stringent quality management system for our GMP iPSCs. Please inquire for more details. 

Our donor screeningand eligibility is compliant with 21 CFR 1271 and Japanese donor eligibility recommendation

We use Sendai Virus to induce iPSCs

We are licensed by the Japanese Ministry of Health, Labor, and Welfare and audited by the PMDA. USFDA’s cGMP regulations are built into the design of the facility

Yes, we can do custom manufacturing with client-sourced materials (as long as it passes our acceptance criteria) or source donors meeting client-specified criteria. Reach out to us to learn more.

We have 5 lines available at the moment but are continuously expanding our portfolio.

Yes, we have research-grade iPSC lines established from Master Cell Banks of the GMP lines available for testing. Contact us to learn more.

We prefer to work with PBMCs isolated from whole blood with Ficoll. Please discuss with us if you are interested in using other cell types.

For Individual

Currently, clinical research using iPSCs is being conducted by multiple institutions, but it is still not possible to use it immediately. iPSC banking is a service to prepare for when it becomes available in the future.

As you grow older, the DNA in your cells can become damaged. iPSCs made from cells that have less damage are better suited for future therapeutic applications; therefore it is desirable to make and store iPS cells as early as possible. There are several iPSC-derived cell therapies undergoing clinical trial right now. If you have your iPSCs generated and banked already, you may be able to access them as soon as they’re approved.

Regenerative medicine using iPS cells is advancing in a wide range of fields. Check out our blog to learn about the latest research advances.

The iPSCs may only be used for yourself.

Once we receive an application, we will set up a blood collection appointment. We will test for infectious diseases as part of our acceptance criteria and once the test results come back negative, we will start the iPSC generation and storage process.

iPSCs are pluripotent, meaning they can differentiate into any cell type of the body. iPSCs have a clear advantage over other stems cells such as MSCs, HSCs, or dental pulp stem cells due to their pluripotency and ability to be generated from anyone’s cells.

Research is currently underway for iPSC-derived cell therapy for various diseases. If you generate and store your own iPSCs in advance, you will be able to access them as soon as treatments are approved.

Although a cancer gene is used to generate iPSCs, our stringent QC process ensures there are no residual genes in the cells. There is no evidence showing that risk of cancer with iPSCs is increased compared with other cell therapy.

$20,000 USD / ¥2,000,000 plus annual banking fee.

Generally, anyone can bank their iPSCs. Please consult with us if you have any concerns.

Tokyo Toyosu Cancer Clinic (Tokyo), Seta Clinic (Tokyo), and Kajiyama Clinic (Kyoto)

In most cases, you can still generate and bank your iPSCs. Reach out to us.

There is no minimum or maximum age limit for banking iPSCs. Since we perform viral testing for regulatory compliance, we do need 30 mL (about two tablespoons) of blood and recognize that this may be too burdensome for very young children. Reach out to us to discuss your specific situation.

We use a special reagent and method to make sure the cells maintain their viability after freezing

Cryopreservation does not impact quality. In fact, since it takes time to evaluate the quality of a manufactured cell product, iPSCs that are generated, stored, and evaluated for quality prior to being needed makes them easier to use. This means a quicker route to treatment once there is an approved treatment.

We highly encourage informing your primary care doctor about your banked iPSCs. Once there are approved clinical uses for iPSCs, your doctor will reach out to I Peace to facilitate transfer of the stored iPSCs to the institution that will generate the cell therapy product for transplantation.

iPSC-derived cell therapy is a new and quickly growing field. The risk with banking your iPSCs is that there is no guarantee there will be an approved iPSC-derived cell therapy for the disease or treatment you need when you need it. While there have been multiple studies that discuss the potential mutagenicity of iPSCs, subsequent studies have shown no increased risk. Take a look at our blog for more information.

We have highly trained Certified Clinical Cell Product Technicians that have deep expertise in manufacturing iPSCs for clinical use. In addition to experience manufacturing cells in a sterile, clean environment of a GMP facility, our technicians also understand the intricacies of iPSC manufacturing.

About iPSCs

Induced pluripotent stem cells (iPS cells or iPSCs) are stem cells induced from somatic cells that are reprogrammed to an embryonic stem cell-like state by introducing special factors (genes). iPSCs are able to become any type of cells in the body and proliferate almost indefinitely, like an embryonic stem cell. Thus, iPSCs provide for an unlimited source of any type of human cell needed for therapeutic purposes.

Mouse iPSC were first reported in 2006, and human iPSCs were first reported in late 2007.

The iPSC technology was pioneered by a Japanese scientist Shinya Yamanaka, a professor of Kyoto University, Japan. He shared the Nobel Prize in Physiology or Medicine 2012 with Sir John Gurdon for the discovery that cells from adult tissues can be reprogrammed to become pluripotent.

I Peace’s CEO Koji Tanabe is a second author of a paper that reported the successful production of human iPS cells for the first time in the world.

iPSCs are generated from adult somatic cells such as skin or blood cells by introducing reprograming factors (genes) using vectors such as plasmids, RNA or viral vectors. I Peace is manufacturing iPS cells by introducing reprogramming genes in a way that does not damage DNA.

There are two main ways to apply iPSC technology. One is the so-called regenerative medicine, where cells such as neurons and heart cells derived from their own iPSCs, or those from another, are generated and transplanted. If one receives their own iPSC-derived cells one benefits from minimized risk of immune rejection. The other is to use patient-derived iPSCs and convert them into cells specific to their disease and use for research such as drug discovery screening, toxicity testing, and studying the mechanism of disease by reproducing the disease state in vitro.

iPSCs have the following three features:

  1. Potential ability to be generated from any cell type in the body.
    iPSCs can be made by introducing four genetic factors into a variety of cell types such as blood cells, skin cells, or hair cells and then growing those cells until reprogramming is complete. With the current technology, iPSCs can be made with just 5 mL of blood.

  2. Being able to transform into cells of various tissues and organs.
    A major feature of iPSCs is that they have “pluripotency”. Pluripotency means being able to become any cell type, such as neurons or heart muscle cells, etc.

  3. Have the ability to proliferate almost indefinitely
    Since iPSCs can divide and proliferate rapidly, they can be easily cultured and expanded to obtain the needed number of cells.

There are two major categories of stem cells, adult or cord blood stem cells and pluripotent stem cells.

  1. Advantages of iPSCs over these stem cells
    iPSCs are unrivaled as patient-derived stem cells in their ability to differentiate into all tissue and cell types. iPSCs can be made from an individual person of any age from a small blood or skin sample.

    iPSCs also possess the ability to proliferate in cell culture almost indefinitely and are therefore the ultimate source of material for cell based and tissue regeneration therapy.

  2. Mesenchymal Stem Cell
    MSCs can be isolated from cord blood, as well as from bone marrow, placenta, adipose tissue, dental pulp and other organs. They show relatively narrow multipotent differentiation into various cell types both in culture and when transplanted autologously. Their use in cell therapy is however, largely unregulated.
  3. Dental Pulp Stem Cell
    Dental pulp stem cells (DPSCs) are a specific type of mesenchymal stem cells (MSCs) from the inner tooth that show relatively broad multipotent differentiation into various cell types both in culture and when transplanted. they can differentiate in several cell-populations such as odontoblast, osteoblasts, neural cells, chondrocytes, adipocytes, myoblasts, fibroblasts, and endothelial cells. They have greater proliferative capacity than many other MSCs, including those from cord blood, but still limited compared with iPSCs. They have been useful not only for dental diseases, but also for systemic diseases.
  4. Cord Blood Hematopoetic Stem Cells
    Cord blood is normally collected after the baby is delivered and the cord is cut. Cord blood contains blood-forming stem cells that can be used in the treatment of patients with blood cancers such as leukemias and lymphomas, as well as certain disorders of the blood and immune systems, such as sickle cell disease and Wiskott-Aldrich syndrome. There are three major differences between cord blood stem cell and pluripotent stem cells (iPSCs and ESCs). Firstly, cord blood stem cell can differentiate only into blood cells whereas pluripotent stem cells can differentiate into various type of cells. Therefore, cord blood is approved only for use in “hematopoietic stem cell transplantation” procedures. Secondly, cord blood hematopoietic stem cells can only be produced from cells in baby’s cord. Lastly, iPS cells and ES cells can proliferate indefinitely, whereas cord blood hematopoietic stem cells are difficult to be expanded, making it difficult to obtain the amount required for transplantation.

 

There are three major differences between iPSCs and ESCs: The origin of the cells, ethical issues and risks of immune rejection. ESCs are derived from the inner cell mass of a blastocyst‐stage embryo before the soma and the germ cell lineages separate and the embryo is destroyed in the process. In contrast, iPSCs are derived from easily isolated somatic cells, without harm to the donor. Thus, the iPSC production method does not require the destruction of an embryo. It avoids the ethical issues that surround the use of human ES cells. Furthermore, unlike human ES cells, it is possible to generate donor-specific iPS cells and convert them into various types of cells, which can be transplanted back into the patient with minimized risk of immune rejection.

Yes, iPSCs can be made from people of any age.

Theoretically, iPS cells are capable of differentiating into cells of all types of organs including nervous system, cardiac muscle, and blood. However, organs are more complex because of their three-dimensional (3D) tissue structure. Therefore, it is not easy to form functional three dimensional-organs from pluripotent stem cells. Formation of small livers have been reported, but there are as yet no reports of large 3D, functional organs of human size. This is an area that requires further development by combining iPS cell technologies, more sophisticated use of 3D printers, biomaterials, and other technologies. At this moment, research on the formation and the application of cell sheets will precede generation of iPSC-derived functional three-dimensional organs. In January 2020, Osaka University in Japan announced that they had conducted the world’s first clinical trial for transplanting iPS cell-derived cardiac sheets onto a patient’s heart with severe failure.

Clinical research on the diseases listed below has already begun. However,
Research on diseases other than those listed below has also been studied.

AMD (Age-related macular degeneration), Corneal disease, Retinitis Pigmentosa, Spinal Cord Injury, Graft versus host disease, Muscular Dystrophy, Diabetes, Parkinsons Disease, Pendred Syndrome, Heart Disease, CAR-T Cell Therapy, NK Cell Cancer, Hematologic Malignancies
Blood Transfusion/aplastic anemia.

<Advantages>

  1. Issues of histocompatibility with donor/recipient transplants can be avoided iPSCs can be generated from the patient’s own cells so that iPS-derivedcell transplantation with minimal risk of immune rejection is possible.

  2. Ethical Issue can be avoided The advantage of iPSCs is that they are not derived from human embryos, which is the ethical concern in this field. By removing the bioethical issues, the scientists are likely to be able to obtain more federal funding and support. Moreover, patient who bank their own clinical-grade iPSCs are primed to take advantage of any newly emerging cell-based therapy.

  3. Useful for drug development and disease mechanism studies iPSCs are useful tool for disease modeling. Cells such as neurons and cardiomyocytes made from iPSCs derived from patient’s blood, etc., can have the same phenotype as the patients’ cells in the body. Cells with the characteristics of the disease can thus be cultured on a culture dish to observe the disease state. In other words, you can reproduce the disease state in vitro and observe the nature and mechanism of the disease. In addition, it is possible to confirm the effect and toxicity of drugs in vitro by applying various compounds, such as drug candidates, to the cells. Another significant benefit of iPS cell technology would permit for creation of isogenic control cell lines using CRISPR/Cas9 gene editing that are genetically tailored to model a disease phenotype.

With numerous advantages as mentioned above, we don’t see any disadvantage in iPSC.

 

Disease-specific iPSCs are useful for drug discovery.
iPSCs derived from patients with a variety of diseases. Disease-specific iPSCs offer an opportunity to recapitulate both normal and pathologic human tissue formation in vitro. They can have the same phenotype as the patients’ cells in the body. Cells with the characteristics of the disease can thus be cultured on a culture dish to study the nature and treatment of the disease state. In addition, it is possible to confirm the effect and toxicity of drugs in vitro by applying various compounds, such as drug candidates, to the cells.

The overarching issue for application of iPSCs in personalized medicine is that it must become possible to have clinic-ready patient-derived iPSC lines available to all aspects of stem cell research and clinical application. Our approach using robotics and a closed, miniaturized fluidic system will allow for mass parallel derivation within a GMP facility. This means that our iPSCs products will be available not only to patients when needed, but also to researchers striving to understand the basis of disease at the cell and molecular level, with fidelity of the individual cell genotype (genome sequence) and disease phenotype (for example, how a drug influences disease progression in an individual’s cells).

The overarching issue for application of iPSCs in personalized medicine is that it must become possible to have clinic-ready patient-derived iPSC lines available to all aspects of stem cell research and clinical application. Our approach using robotics and a closed, miniaturized fluidic system will allow for mass parallel derivation within a GMP facility. This means that our iPSCs products will be available to patients when needed, but also to researchers striving to understand the basis of disease at the cell and molecular level, with fidelity of the individual cell genotype (genome sequence) and disease phenotype (for example, how a drug influences disease progression in an individual cells).

iPSCs have already been used for drug screenings and its use is expected to expand rapidly.
In regenerative medicine, since Professor Shinya Yamanaka announced the successful generation of human iPSCs in 2007, various studies have been conducted for clinical applications in Japan, US and in many other countries. Examples of diseases for which clinical research has already begun include age-related macular degeneration, Parkinson’s disease, severe ischemic cardiomyopathy, and spinal cord injury. In addition, research is being conducted on application to diabetes, corneal disease, cerebral infarction, and liver and kidney diseases, among many others.
Also, CAR-T cell therapy research is attracting attention as one example of cancer treatment using iPSCs. This is an immunotherapy in which a patient’s blood-derived iPSCs are genetically modified to produce T immune cells that can recognize and attack specific cancer cells when returned to the patient’s body.

Not for the moment, but we are hoping that iPS cells will eventually be able to replace most, if not all, of the need for organ transplant. For this end, it’s important that autologous (obtained from oneself) iPS cell banking gains public support and demand. To achieve this, we continue our efforts to further reduce the cost of iPS cells production.

It seems that no company other than I Peace has succeeded in developing a fully closed system iPS cell automatic production system.

The key element is that it enables miniaturized and robotic mass production of clinical-grade iPS cells from a large number of donors simultaneously in a single room.

Manufacturing cost (NOT selling price) of clinical-grade iPSCs has been more than $1,000,000. I Peace, Inc has succeeded in lowering the direct manufacturing cost to several tens of thousand dollars.

Currently, there are very few iPSC provider worldwide that can manufacture clinical grade iPSCs on a contract basis. We support clinical research using iPS cells by simultaneously providing multiple clinical-grade iPS cell lines. We can and will provide large quantities of research grade iPS cells to institutions who conducts drug screenings.

He has been involved in iPSC research since the beginning of iPSC development, and is the second author of a paper reporting the successful establishment of human iPS cells for the first time in the world. He researched the mechanism of reprogramming for 7 years at Dr. Shinya Yamanaka’s lab. As a postdoctoral researcher at Stanford University in the laboratory of Dr. Marius Werning who succeeded in the direct reprogramming from skin cells to neurons for the first time in the world, his work focused on the mechanism of direct reprogramming from blood cells to neurons and iPSC reprogramming. He has contributed to numerous papers on both iPSCs and the direct reprogramming into neurons.

We perform a wide variety of assays for our research and GMP-grade iPSCs including pluripotency marker expression by flow cytometry and cell-based immunofluorescence assay, karyotyping, microarray analysis, residual vector testing, sterility, endotoxin, mycoplasma testing, etc. We use validated and GMP-appropriate assays performed under a stringent quality management system for our GMP iPSCs. Please inquire for more details. 

Our donor screeningand eligibility is compliant with 21 CFR 1271 and Japanese donor eligibility recommendation

We use Sendai Virus to induce iPSCs

We are licensed by the Japanese Ministry of Health, Labor, and Welfare and audited by the PMDA. USFDA’s cGMP regulations are built into the design of the facility

Yes, we can do custom manufacturing with client-sourced materials (as long as it passes our acceptance criteria) or source donors meeting client-specified criteria. Reach out to us to learn more.

We have 5 lines available at the moment but are continuously expanding our portfolio.

Yes, we have research-grade iPSC lines established from Master Cell Banks of the GMP lines available for testing. Contact us to learn more.

We prefer to work with PBMCs isolated from whole blood with Ficoll. Please discuss with us if you are interested in using other cell types.

Currently, clinical research using iPSCs is being conducted by multiple institutions, but it is still not possible to use it immediately. iPSC banking is a service to prepare for when it becomes available in the future.

As you grow older, the DNA in your cells can become damaged. iPSCs made from cells that have less damage are better suited for future therapeutic applications; therefore it is desirable to make and store iPS cells as early as possible. There are several iPSC-derived cell therapies undergoing clinical trial right now. If you have your iPSCs generated and banked already, you may be able to access them as soon as they’re approved.

Regenerative medicine using iPS cells is advancing in a wide range of fields. Check out our blog to learn about the latest research advances.

The iPSCs may only be used for yourself.

Once we receive an application, we will set up a blood collection appointment. We will test for infectious diseases as part of our acceptance criteria and once the test results come back negative, we will start the iPSC generation and storage process.

iPSCs are pluripotent, meaning they can differentiate into any cell type of the body. iPSCs have a clear advantage over other stems cells such as MSCs, HSCs, or dental pulp stem cells due to their pluripotency and ability to be generated from anyone’s cells.

Research is currently underway for iPSC-derived cell therapy for various diseases. If you generate and store your own iPSCs in advance, you will be able to access them as soon as treatments are approved.

Although a cancer gene is used to generate iPSCs, our stringent QC process ensures there are no residual genes in the cells. There is no evidence showing that risk of cancer with iPSCs is increased compared with other cell therapy.

$20,000 USD / ¥2,000,000 plus annual banking fee.

Generally, anyone can bank their iPSCs. Please consult with us if you have any concerns.

Tokyo Toyosu Cancer Clinic (Tokyo), Seta Clinic (Tokyo), and Kajiyama Clinic (Kyoto)

In most cases, you can still generate and bank your iPSCs. Reach out to us.

There is no minimum or maximum age limit for banking iPSCs. Since we perform viral testing for regulatory compliance, we do need 30 mL (about two tablespoons) of blood and recognize that this may be too burdensome for very young children. Reach out to us to discuss your specific situation.

We use a special reagent and method to make sure the cells maintain their viability after freezing

Cryopreservation does not impact quality. In fact, since it takes time to evaluate the quality of a manufactured cell product, iPSCs that are generated, stored, and evaluated for quality prior to being needed makes them easier to use. This means a quicker route to treatment once there is an approved treatment.

We highly encourage informing your primary care doctor about your banked iPSCs. Once there are approved clinical uses for iPSCs, your doctor will reach out to I Peace to facilitate transfer of the stored iPSCs to the institution that will generate the cell therapy product for transplantation.

iPSC-derived cell therapy is a new and quickly growing field. The risk with banking your iPSCs is that there is no guarantee there will be an approved iPSC-derived cell therapy for the disease or treatment you need when you need it. While there have been multiple studies that discuss the potential mutagenicity of iPSCs, subsequent studies have shown no increased risk. Take a look at our blog for more information.

We have highly trained Certified Clinical Cell Product Technicians that have deep expertise in manufacturing iPSCs for clinical use. In addition to experience manufacturing cells in a sterile, clean environment of a GMP facility, our technicians also understand the intricacies of iPSC manufacturing.

Induced pluripotent stem cells (iPS cells or iPSCs) are stem cells induced from somatic cells that are reprogrammed to an embryonic stem cell-like state by introducing special factors (genes). iPSCs are able to become any type of cells in the body and proliferate almost indefinitely, like an embryonic stem cell. Thus, iPSCs provide for an unlimited source of any type of human cell needed for therapeutic purposes.

Mouse iPSC were first reported in 2006, and human iPSCs were first reported in late 2007.

The iPSC technology was pioneered by a Japanese scientist Shinya Yamanaka, a professor of Kyoto University, Japan. He shared the Nobel Prize in Physiology or Medicine 2012 with Sir John Gurdon for the discovery that cells from adult tissues can be reprogrammed to become pluripotent.

I Peace’s CEO Koji Tanabe is a second author of a paper that reported the successful production of human iPS cells for the first time in the world.

iPSCs are generated from adult somatic cells such as skin or blood cells by introducing reprograming factors (genes) using vectors such as plasmids, RNA or viral vectors. I Peace is manufacturing iPS cells by introducing reprogramming genes in a way that does not damage DNA.

There are two main ways to apply iPSC technology. One is the so-called regenerative medicine, where cells such as neurons and heart cells derived from their own iPSCs, or those from another, are generated and transplanted. If one receives their own iPSC-derived cells one benefits from minimized risk of immune rejection. The other is to use patient-derived iPSCs and convert them into cells specific to their disease and use for research such as drug discovery screening, toxicity testing, and studying the mechanism of disease by reproducing the disease state in vitro.

iPSCs have the following three features:

  1. Potential ability to be generated from any cell type in the body.
    iPSCs can be made by introducing four genetic factors into a variety of cell types such as blood cells, skin cells, or hair cells and then growing those cells until reprogramming is complete. With the current technology, iPSCs can be made with just 5 mL of blood.

  2. Being able to transform into cells of various tissues and organs.
    A major feature of iPSCs is that they have “pluripotency”. Pluripotency means being able to become any cell type, such as neurons or heart muscle cells, etc.

  3. Have the ability to proliferate almost indefinitely
    Since iPSCs can divide and proliferate rapidly, they can be easily cultured and expanded to obtain the needed number of cells.

There are two major categories of stem cells, adult or cord blood stem cells and pluripotent stem cells.

  1. Advantages of iPSCs over these stem cells
    iPSCs are unrivaled as patient-derived stem cells in their ability to differentiate into all tissue and cell types. iPSCs can be made from an individual person of any age from a small blood or skin sample.

    iPSCs also possess the ability to proliferate in cell culture almost indefinitely and are therefore the ultimate source of material for cell based and tissue regeneration therapy.

  2. Mesenchymal Stem Cell
    MSCs can be isolated from cord blood, as well as from bone marrow, placenta, adipose tissue, dental pulp and other organs. They show relatively narrow multipotent differentiation into various cell types both in culture and when transplanted autologously. Their use in cell therapy is however, largely unregulated.
  3. Dental Pulp Stem Cell
    Dental pulp stem cells (DPSCs) are a specific type of mesenchymal stem cells (MSCs) from the inner tooth that show relatively broad multipotent differentiation into various cell types both in culture and when transplanted. they can differentiate in several cell-populations such as odontoblast, osteoblasts, neural cells, chondrocytes, adipocytes, myoblasts, fibroblasts, and endothelial cells. They have greater proliferative capacity than many other MSCs, including those from cord blood, but still limited compared with iPSCs. They have been useful not only for dental diseases, but also for systemic diseases.
  4. Cord Blood Hematopoetic Stem Cells
    Cord blood is normally collected after the baby is delivered and the cord is cut. Cord blood contains blood-forming stem cells that can be used in the treatment of patients with blood cancers such as leukemias and lymphomas, as well as certain disorders of the blood and immune systems, such as sickle cell disease and Wiskott-Aldrich syndrome. There are three major differences between cord blood stem cell and pluripotent stem cells (iPSCs and ESCs). Firstly, cord blood stem cell can differentiate only into blood cells whereas pluripotent stem cells can differentiate into various type of cells. Therefore, cord blood is approved only for use in “hematopoietic stem cell transplantation” procedures. Secondly, cord blood hematopoietic stem cells can only be produced from cells in baby’s cord. Lastly, iPS cells and ES cells can proliferate indefinitely, whereas cord blood hematopoietic stem cells are difficult to be expanded, making it difficult to obtain the amount required for transplantation.

 

There are three major differences between iPSCs and ESCs: The origin of the cells, ethical issues and risks of immune rejection. ESCs are derived from the inner cell mass of a blastocyst‐stage embryo before the soma and the germ cell lineages separate and the embryo is destroyed in the process. In contrast, iPSCs are derived from easily isolated somatic cells, without harm to the donor. Thus, the iPSC production method does not require the destruction of an embryo. It avoids the ethical issues that surround the use of human ES cells. Furthermore, unlike human ES cells, it is possible to generate donor-specific iPS cells and convert them into various types of cells, which can be transplanted back into the patient with minimized risk of immune rejection.

Yes, iPSCs can be made from people of any age.

Theoretically, iPS cells are capable of differentiating into cells of all types of organs including nervous system, cardiac muscle, and blood. However, organs are more complex because of their three-dimensional (3D) tissue structure. Therefore, it is not easy to form functional three dimensional-organs from pluripotent stem cells. Formation of small livers have been reported, but there are as yet no reports of large 3D, functional organs of human size. This is an area that requires further development by combining iPS cell technologies, more sophisticated use of 3D printers, biomaterials, and other technologies. At this moment, research on the formation and the application of cell sheets will precede generation of iPSC-derived functional three-dimensional organs. In January 2020, Osaka University in Japan announced that they had conducted the world’s first clinical trial for transplanting iPS cell-derived cardiac sheets onto a patient’s heart with severe failure.

Clinical research on the diseases listed below has already begun. However,
Research on diseases other than those listed below has also been studied.

AMD (Age-related macular degeneration), Corneal disease, Retinitis Pigmentosa, Spinal Cord Injury, Graft versus host disease, Muscular Dystrophy, Diabetes, Parkinsons Disease, Pendred Syndrome, Heart Disease, CAR-T Cell Therapy, NK Cell Cancer, Hematologic Malignancies
Blood Transfusion/aplastic anemia.

<Advantages>

  1. Issues of histocompatibility with donor/recipient transplants can be avoided iPSCs can be generated from the patient’s own cells so that iPS-derivedcell transplantation with minimal risk of immune rejection is possible.

  2. Ethical Issue can be avoided The advantage of iPSCs is that they are not derived from human embryos, which is the ethical concern in this field. By removing the bioethical issues, the scientists are likely to be able to obtain more federal funding and support. Moreover, patient who bank their own clinical-grade iPSCs are primed to take advantage of any newly emerging cell-based therapy.

  3. Useful for drug development and disease mechanism studies iPSCs are useful tool for disease modeling. Cells such as neurons and cardiomyocytes made from iPSCs derived from patient’s blood, etc., can have the same phenotype as the patients’ cells in the body. Cells with the characteristics of the disease can thus be cultured on a culture dish to observe the disease state. In other words, you can reproduce the disease state in vitro and observe the nature and mechanism of the disease. In addition, it is possible to confirm the effect and toxicity of drugs in vitro by applying various compounds, such as drug candidates, to the cells. Another significant benefit of iPS cell technology would permit for creation of isogenic control cell lines using CRISPR/Cas9 gene editing that are genetically tailored to model a disease phenotype.

With numerous advantages as mentioned above, we don’t see any disadvantage in iPSC.

 

Disease-specific iPSCs are useful for drug discovery.
iPSCs derived from patients with a variety of diseases. Disease-specific iPSCs offer an opportunity to recapitulate both normal and pathologic human tissue formation in vitro. They can have the same phenotype as the patients’ cells in the body. Cells with the characteristics of the disease can thus be cultured on a culture dish to study the nature and treatment of the disease state. In addition, it is possible to confirm the effect and toxicity of drugs in vitro by applying various compounds, such as drug candidates, to the cells.

The overarching issue for application of iPSCs in personalized medicine is that it must become possible to have clinic-ready patient-derived iPSC lines available to all aspects of stem cell research and clinical application. Our approach using robotics and a closed, miniaturized fluidic system will allow for mass parallel derivation within a GMP facility. This means that our iPSCs products will be available not only to patients when needed, but also to researchers striving to understand the basis of disease at the cell and molecular level, with fidelity of the individual cell genotype (genome sequence) and disease phenotype (for example, how a drug influences disease progression in an individual’s cells).

The overarching issue for application of iPSCs in personalized medicine is that it must become possible to have clinic-ready patient-derived iPSC lines available to all aspects of stem cell research and clinical application. Our approach using robotics and a closed, miniaturized fluidic system will allow for mass parallel derivation within a GMP facility. This means that our iPSCs products will be available to patients when needed, but also to researchers striving to understand the basis of disease at the cell and molecular level, with fidelity of the individual cell genotype (genome sequence) and disease phenotype (for example, how a drug influences disease progression in an individual cells).

iPSCs have already been used for drug screenings and its use is expected to expand rapidly.
In regenerative medicine, since Professor Shinya Yamanaka announced the successful generation of human iPSCs in 2007, various studies have been conducted for clinical applications in Japan, US and in many other countries. Examples of diseases for which clinical research has already begun include age-related macular degeneration, Parkinson’s disease, severe ischemic cardiomyopathy, and spinal cord injury. In addition, research is being conducted on application to diabetes, corneal disease, cerebral infarction, and liver and kidney diseases, among many others.
Also, CAR-T cell therapy research is attracting attention as one example of cancer treatment using iPSCs. This is an immunotherapy in which a patient’s blood-derived iPSCs are genetically modified to produce T immune cells that can recognize and attack specific cancer cells when returned to the patient’s body.

Not for the moment, but we are hoping that iPS cells will eventually be able to replace most, if not all, of the need for organ transplant. For this end, it’s important that autologous (obtained from oneself) iPS cell banking gains public support and demand. To achieve this, we continue our efforts to further reduce the cost of iPS cells production.

It seems that no company other than I Peace has succeeded in developing a fully closed system iPS cell automatic production system.

The key element is that it enables miniaturized and robotic mass production of clinical-grade iPS cells from a large number of donors simultaneously in a single room.

Manufacturing cost (NOT selling price) of clinical-grade iPSCs has been more than $1,000,000. I Peace, Inc has succeeded in lowering the direct manufacturing cost to several tens of thousand dollars.

Currently, there are very few iPSC provider worldwide that can manufacture clinical grade iPSCs on a contract basis. We support clinical research using iPS cells by simultaneously providing multiple clinical-grade iPS cell lines. We can and will provide large quantities of research grade iPS cells to institutions who conducts drug screenings.

He has been involved in iPSC research since the beginning of iPSC development, and is the second author of a paper reporting the successful establishment of human iPS cells for the first time in the world. He researched the mechanism of reprogramming for 7 years at Dr. Shinya Yamanaka’s lab. As a postdoctoral researcher at Stanford University in the laboratory of Dr. Marius Werning who succeeded in the direct reprogramming from skin cells to neurons for the first time in the world, his work focused on the mechanism of direct reprogramming from blood cells to neurons and iPSC reprogramming. He has contributed to numerous papers on both iPSCs and the direct reprogramming into neurons.

Reach out to us to learn more