Focus Areas of ISSCR Policy


Supporting Stem Cell Research and Research Funding

The ISSCR supports all forms of stem cell research, performed under rigorous and transparent oversight, and advocates that embryonic, adult, and reprogrammed stem cell research must move forward in parallel to best understand disease and identify treatment.

Human embryonic stem cells have the potential to make any cell type in the body in unlimited quantities. Research in this area is producing innovative new approaches to treat diseases that represent major public health problems, and cells derived from human embryonic stem cells are now being tested in clinical trials as treatments for diabetes, spinal cord injury, heart failure, macular degeneration and Stargardt’s macular dystrophy. 

Fetal tissue research has been critical for scientific and medical advances that have saved the lives of millions of people, including the development of vaccines against polio, rubella, measles, chickenpox, adenovirus, rabies, as well as treatments for debilitating diseases such as rheumatoid arthritis, cystic fibrosis, and hemophilia. 

The ISSCR supports rigorous funding to advance treatments for disease, protect investments in science, and ensure that the economy continues to benefit from the significant contributions that science and biomedical research provide.

Recent advances in stem cell research, gene therapy, genomics, and cancer biology have created unprecedented opportunities to create new treatments for human disease. However, decreased funding investments and budget cuts could slow the development of new cures and cause long-term damage to the international research infrastructure and to public health efforts around the world.

Related articles: Preventing the Marketing of Unproven Stem Cell Treatments

October, 2019: ISSCR Comments on Brazil’s Advanced Therapy Medicinal Products Regulation

September, 2019: ISSCR Applauds Google’s New Policy Banning Ads on Unproven Therapies

June, 2019: ISSCR Statement re District Court Ruling Against US Stem Cell

May, 2019: ISSCR Comments on China's Proposal re Management of Clinical Research and Transformation Applications for Somatic Cell Therapy
 
May, 2019: ISSCR Comments on Health Canada's Autologous Cell Therapy Policy

March, 2019: ISSCR Comments on China's draft New Biomedical Technology Regulations

March, 2019: Letter from ISSCR to Leadership of Texas House of Representatives Opposing Right to Try Legislation

December, 2018: ISSCR Writes to Mexican Secretary of Health Regarding Stem Cell and Tissue Regulation

November, 2018: ISSCR Comments on FDA Proposed Industry Guidance for Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
 
June, 2018: ISSCR Writes to Canadian Minister of Health Regarding Health Canada's Guidance on the Regulation of Cell Therapy Products

May, 2018: ISSCR Applauds Federal Injunctions Against Stem Cell Clinics

May, 2018: ISSCR Writes to Department of Health, Drug Office of Hong Kong Regarding Department of Health's Consultation Document for the Regulation of Advanced Therapy Products

May, 2018: ISSCR Writes to the Drugs Controller General of India Regarding Regulation of Stem Cell and Cell-based Products

 
March, 2018: ISSCR Writes to Australian Therapeutic Goods Administration Regarding Regulations for Autologous Cell and Tissue Products

March, 2018: Letter from ISSCR to Leadership of U.S. House of Representatives Opposing Right to Try

February, 2018: Letter from ISSCR and Patient Organizations to U.S. House of Representatives Leadership re "Right to Try"  

November, 2017: ISSCR Applauds the FDA Announcement of New Guidelines for Cellular Therapies and Cell-based Tissue Products

October, 2017: ISSCR Applauds California Bill to Assist Stem Cell Patients

August, 2017: ISSCR Responds to FDA Announcement of Enforcement Direction for Stem Cell Treatments

August, 2017: Letter to U.S. House of Representatives Energy & Commerce Committee re "Right to Try" Legislation

July, 2017: ISSCR Endorses California Senate Bill 512

June, 2017: Letter to Massachusetts Legislature Regarding "Right to Try" Legislation

June, 2017: Letter to India Secretary of Department of Biotechnology Regarding Unproven Therapy Clinics in India

May, 2017: Letter to Texas House of Representatives, U.S., Opposing Legislation It Says Would Put Patients at Risk

December, 2016: ISSCR Comments on 21st Century Cures Act in U.S.

November, 2016: ISSCR Comments to Australian Therapeutic Goods Administration on Regulation of Autologous Cell and Tissue Products


The Promotion of Scientific Integrity and Ethical Research

The ISSCR promotes rigorous standards for research integrity, patient welfare, respect for research subjects, transparency, and social justice, as outlined in its Guidelines for Stem Cell Research and Clinical Translation (2016). At their core, the guidelines preserve the imperative for a specialized oversight process for research involving human embryos, in recognition of the unique sensitivities surrounding such research.

Responding to advances in science, the guidelines encompass a broader and more expansive scope of research and clinical endeavor than before, imposing rigor on all stages of the research, addressing the cost of regenerative medicine products, and highlighting the need for accurate and effective public communication. 

Chimera Research

The ISSCR recognizes that the study of animal models containing human cells has long produced valuable insights into human biology and disease. Research that incorporates human pluripotent stem cells - those that can potentially turn into any cell type in the body - into non-humans is called chimerism. In 2016, the National Institutes of Health proposed ending a moratorium on this this research, and the ISSCR supported that effort.

The 2016 Guidelines for Stem Cell Research and Clinical Translation address chimera research in Recommendation 2.1.5, which calls for specialized oversight grounded in rigorous scientific knowledge and ethical considerations and with a diligent application of animal welfare principles. The ISSCR also has an Advisory Report on chimera research. We believe rigorous, responsibly-monitored research in this area will lead to great advances in science, and to developments for the field of regenerative medicine.

Participate in Standard-setting Forums

A leading voice in the stem cell field, the ISSCR is in dialogue with a number of international bodies in setting standards and practices for stem cell science and its translation to clinical application. It fully participates in discussions of science and technology, and social and ethical considerations of  advances in regenerative medicine.

ISSCR also works with the Standards Coordinating Body (SCB), which serves as a source of knowledge, experience and leadership in enabling more efficient and successful clinical and commercial development of cellular/gene & regenerative medicine therapies. It coordinates and prioritizes development of standards for areas including measurement assurance, improved analytics, and reference standards for characterization, potency, purity, and other essential regulatory requirements. ISSCR staff participate in deliberations on the four SCB Sectors: Cell-Based Drug Discovery (DD), Cell Therapy (CT), Gene Therapy (GT), and Tissue Engineering (TE).

In addition, the ISSCR is part of the National Academies of Sciences Regenerative Medicine Forum, which brings together academia, industry, government, patient/provider organizations, regulators, foundations, and others to discuss difficult issues in a neutral setting. The Forum addresses challenges facing the field of regenerative medicine, including the potential barriers to scientific and therapeutic advances, the discovery, development, and translation of regenerative medicine therapies, the unique challenges of identifying, validating, and bringing regenerative medicine applications to market, and the ethical, legal, and social issues posed by regenerative medicine advances.

Related articles: Preventing the Marketing of Unproven Stem Cell Treatments

October, 2019: ISSCR Comments on Brazil’s Advanced Therapy Medicinal Products Regulation

September, 2019: ISSCR Applauds Google’s New Policy Banning Ads on Unproven Therapies

June, 2019: ISSCR Statement re District Court Ruling Against US Stem Cell

May, 2019: ISSCR Comments on China's Proposal re Management of Clinical Research and Transformation Applications for Somatic Cell Therapy
 
May, 2019: ISSCR Comments on Health Canada's Autologous Cell Therapy Policy

March, 2019: ISSCR Comments on China's draft New Biomedical Technology Regulations

March, 2019: Letter from ISSCR to Leadership of Texas House of Representatives Opposing Right to Try Legislation

December, 2018: ISSCR Writes to Mexican Secretary of Health Regarding Stem Cell and Tissue Regulation

November, 2018: ISSCR Comments on FDA Proposed Industry Guidance for Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
 
June, 2018: ISSCR Writes to Canadian Minister of Health Regarding Health Canada's Guidance on the Regulation of Cell Therapy Products

May, 2018: ISSCR Applauds Federal Injunctions Against Stem Cell Clinics

May, 2018: ISSCR Writes to Department of Health, Drug Office of Hong Kong Regarding Department of Health's Consultation Document for the Regulation of Advanced Therapy Products

May, 2018: ISSCR Writes to the Drugs Controller General of India Regarding Regulation of Stem Cell and Cell-based Products

 
March, 2018: ISSCR Writes to Australian Therapeutic Goods Administration Regarding Regulations for Autologous Cell and Tissue Products

March, 2018: Letter from ISSCR to Leadership of U.S. House of Representatives Opposing Right to Try

February, 2018: Letter from ISSCR and Patient Organizations to U.S. House of Representatives Leadership re "Right to Try"  

November, 2017: ISSCR Applauds the FDA Announcement of New Guidelines for Cellular Therapies and Cell-based Tissue Products

October, 2017: ISSCR Applauds California Bill to Assist Stem Cell Patients

August, 2017: ISSCR Responds to FDA Announcement of Enforcement Direction for Stem Cell Treatments

August, 2017: Letter to U.S. House of Representatives Energy & Commerce Committee re "Right to Try" Legislation

July, 2017: ISSCR Endorses California Senate Bill 512

June, 2017: Letter to Massachusetts Legislature Regarding "Right to Try" Legislation

June, 2017: Letter to India Secretary of Department of Biotechnology Regarding Unproven Therapy Clinics in India

May, 2017: Letter to Texas House of Representatives, U.S., Opposing Legislation It Says Would Put Patients at Risk

December, 2016: ISSCR Comments on 21st Century Cures Act in U.S.

November, 2016: ISSCR Comments to Australian Therapeutic Goods Administration on Regulation of Autologous Cell and Tissue Products


Preventing the Marketing of Unproven Stem Cell Treatments

The marketing of unproven treatments raises major ethical and integrity concerns and may jeopardize the safety of patients. Patient welfare and transparency in all communications are core principles of the ISSCR 2016 Guidelines for Stem Cell Research and Clinical Translation, which help assure the public of the integrity of stem cell science and its translation to medicine. The ISSCR guidelines call for processing and manufacture of any cell product as well as the conduct of clinical trials to be performed under expert, independent review and oversight.

 

"Right to Try" Legislation

The ISSCR strongly opposes so-called “right to try” laws and legislation that would allow investigational agents to be provided to patients outside of the context of a clinical trial, without first establishing their safety and efficacy through rigorous clinical trials. Using unproven treatments on significant numbers of patients, particularly in a for-profit context, raises major ethical and integrity concerns and jeopardizes patient safety. 

Related articles: Preventing the Marketing of Unproven Stem Cell Treatments

October, 2019: ISSCR Comments on Brazil’s Advanced Therapy Medicinal Products Regulation

September, 2019: ISSCR Applauds Google’s New Policy Banning Ads on Unproven Therapies

June, 2019: ISSCR Statement re District Court Ruling Against US Stem Cell

May, 2019: ISSCR Comments on China's Proposal re Management of Clinical Research and Transformation Applications for Somatic Cell Therapy
 
May, 2019: ISSCR Comments on Health Canada's Autologous Cell Therapy Policy

March, 2019: ISSCR Comments on China's draft New Biomedical Technology Regulations

March, 2019: Letter from ISSCR to Leadership of Texas House of Representatives Opposing Right to Try Legislation

December, 2018: ISSCR Writes to Mexican Secretary of Health Regarding Stem Cell and Tissue Regulation

November, 2018: ISSCR Comments on FDA Proposed Industry Guidance for Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
 
June, 2018: ISSCR Writes to Canadian Minister of Health Regarding Health Canada's Guidance on the Regulation of Cell Therapy Products

May, 2018: ISSCR Applauds Federal Injunctions Against Stem Cell Clinics

May, 2018: ISSCR Writes to Department of Health, Drug Office of Hong Kong Regarding Department of Health's Consultation Document for the Regulation of Advanced Therapy Products

May, 2018: ISSCR Writes to the Drugs Controller General of India Regarding Regulation of Stem Cell and Cell-based Products

 
March, 2018: ISSCR Writes to Australian Therapeutic Goods Administration Regarding Regulations for Autologous Cell and Tissue Products

March, 2018: Letter from ISSCR to Leadership of U.S. House of Representatives Opposing Right to Try

February, 2018: Letter from ISSCR and Patient Organizations to U.S. House of Representatives Leadership re "Right to Try"  

November, 2017: ISSCR Applauds the FDA Announcement of New Guidelines for Cellular Therapies and Cell-based Tissue Products

October, 2017: ISSCR Applauds California Bill to Assist Stem Cell Patients

August, 2017: ISSCR Responds to FDA Announcement of Enforcement Direction for Stem Cell Treatments

August, 2017: Letter to U.S. House of Representatives Energy & Commerce Committee re "Right to Try" Legislation

July, 2017: ISSCR Endorses California Senate Bill 512

June, 2017: Letter to Massachusetts Legislature Regarding "Right to Try" Legislation

June, 2017: Letter to India Secretary of Department of Biotechnology Regarding Unproven Therapy Clinics in India

May, 2017: Letter to Texas House of Representatives, U.S., Opposing Legislation It Says Would Put Patients at Risk

December, 2016: ISSCR Comments on 21st Century Cures Act in U.S.

November, 2016: ISSCR Comments to Australian Therapeutic Goods Administration on Regulation of Autologous Cell and Tissue Products

Related articles: Preventing the Marketing of Unproven Stem Cell Treatments

October, 2019: ISSCR Comments on Brazil’s Advanced Therapy Medicinal Products Regulation

September, 2019: ISSCR Applauds Google’s New Policy Banning Ads on Unproven Therapies

June, 2019: ISSCR Statement re District Court Ruling Against US Stem Cell

May, 2019: ISSCR Comments on China's Proposal re Management of Clinical Research and Transformation Applications for Somatic Cell Therapy
 
May, 2019: ISSCR Comments on Health Canada's Autologous Cell Therapy Policy

March, 2019: ISSCR Comments on China's draft New Biomedical Technology Regulations

March, 2019: Letter from ISSCR to Leadership of Texas House of Representatives Opposing Right to Try Legislation

December, 2018: ISSCR Writes to Mexican Secretary of Health Regarding Stem Cell and Tissue Regulation

November, 2018: ISSCR Comments on FDA Proposed Industry Guidance for Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank
 
June, 2018: ISSCR Writes to Canadian Minister of Health Regarding Health Canada's Guidance on the Regulation of Cell Therapy Products

May, 2018: ISSCR Applauds Federal Injunctions Against Stem Cell Clinics

May, 2018: ISSCR Writes to Department of Health, Drug Office of Hong Kong Regarding Department of Health's Consultation Document for the Regulation of Advanced Therapy Products

May, 2018: ISSCR Writes to the Drugs Controller General of India Regarding Regulation of Stem Cell and Cell-based Products

 
March, 2018: ISSCR Writes to Australian Therapeutic Goods Administration Regarding Regulations for Autologous Cell and Tissue Products

March, 2018: Letter from ISSCR to Leadership of U.S. House of Representatives Opposing Right to Try

February, 2018: Letter from ISSCR and Patient Organizations to U.S. House of Representatives Leadership re "Right to Try"  

November, 2017: ISSCR Applauds the FDA Announcement of New Guidelines for Cellular Therapies and Cell-based Tissue Products

October, 2017: ISSCR Applauds California Bill to Assist Stem Cell Patients

August, 2017: ISSCR Responds to FDA Announcement of Enforcement Direction for Stem Cell Treatments

August, 2017: Letter to U.S. House of Representatives Energy & Commerce Committee re "Right to Try" Legislation

July, 2017: ISSCR Endorses California Senate Bill 512

June, 2017: Letter to Massachusetts Legislature Regarding "Right to Try" Legislation

June, 2017: Letter to India Secretary of Department of Biotechnology Regarding Unproven Therapy Clinics in India

May, 2017: Letter to Texas House of Representatives, U.S., Opposing Legislation It Says Would Put Patients at Risk

December, 2016: ISSCR Comments on 21st Century Cures Act in U.S.

November, 2016: ISSCR Comments to Australian Therapeutic Goods Administration on Regulation of Autologous Cell and Tissue Products