Guidelines for the Clinical Translation of Stem Cells

The International Society for Stem Cell Research has released Guidelines for the Clinical Translation of Stem Cells that examine the scientific, clinical, regulatory, ethical and societal issues that must be addressed to ensure that basic stem cell research is responsibly transitioned into appropriate clinical applications.

The guidelines call for rigorous standards in the development of stem cell therapies including stringent evaluation and oversight, a thorough informed consent process, and transparency in operations and reporting. A commentary article in the ISSCR pages of Cell Stem Cell, the official affiliated journal of the ISSCR, summarizes the Guidelines.

The ISSCR acknowledges the evolving state of scientific and clinical knowledge of stem cell-based products, and places responsibility on clinical investigators to work alongside regulators in refining standards of pre-clinical and clinical evaluation. The Guidelines will be reviewed and revised as needed to incorporate new scientific advances and to address specific translational research issues.

The ISSCR also recognizes an urgent need to address the problem of unproven stem cell therapies being marketed directly to patients. While stem cell research holds tremendous promise for the development of new treatments for many serious diseases, nearly all stem cell therapies are new and highly experimental.

Unfortunately, there are clinics around the world that exploit patients’ hopes by offering supposed stem cell therapies, without credible scientific rationale, oversight or other patient protections. The Guidelines for the Clinical Translation of Stem Cells establish standards that can be used to judge the claims made by stem cell clinics and whether the treatments they offer are being developed responsibly. The ISSCR guidelines provide information for patients and their doctors evaluating a stem cell therapy in Appendix 1, a Patient Handbook on Stem Cell Therapies.

The ISSCR Task Force for the Clinical Translation of Stem Cells

The Guidelines for the Clinical Translation of Stem Cells was developed by an international task force of experts in stem cell science and clinical research from 13 countries, led by Dr. Olle Lindvall, Sweden, and Dr. Insoo Hyun, USA. A draft version of the Guidelines was opened for public comment in September, 2008, and this  feedback was discussed by the task force and incorporated into the document. Read the biographies of the members of the ISSCR Task Force on the Clinical Translation of Stem Cells.

Funding

The ISSCR wishes to acknowledge the financial support of the EUROCORES Programme EuroSTELLS, a European Science Foundation (ESF) initiative, supported by the European Commission, Sixth Framework Programme, under contract no. ERAS-CT-2003-980409. Research funding is provided by participating national organizations. EuroSTELLS is managed by the European Medical Research Councils (EMRC) at the ESF. The ISSCR also thanks the Alzheimer’s Research Foundation, The Ellison Medical Foundation, and the Juvenile Diabetes Research Foundation Beta Cell Replacement Advisory Committee for their generous financial support of the Task Force.