The ISSCR urges Italian lawmakers to heed concerns of scientists around the world about the premature practice of unproven stem cell treatments and to recognize the importance of regulatory oversight and patient protection when developing new stem cell medicines.
Shinya Yamanaka, MD, PhD, ISSCR president said, “Stem cells have the potential to improve the treatment of many serious diseases but cell-based therapies present new challenges. In our enthusiasm to advance cures, we must not ignore the laws and regulations that exist to protect patients and ensure that medicines are manufactured under rigorous conditions and then proven safe and effective before being marketed by companies. Patients have been harmed when treatments circumvent the medical regulatory process.”
The ISSCR’s Guidelines for the Clinical Translation of Stem Cells emphasize that processing and manufacture of any cell product should be conducted under expert, independent review and oversight, to ensure as much as possible the quality and safety of the cells. The Guidelines recommend adherence to GMP procedures for extensively manipulated stem cells intended for clinical application. In the United States and Europe, cellular products that are highly manipulated outside of the body before being administered to patients are considered medicines and are subject to regulatory review and oversight by the US Food and Drug Administration and European Medicines Agency, respectively. Moreover, the ISSCR reiterates the value of a strong biological rationale for clinical interventions with stem cell-based products, based on rigorous evidence from pre-clinical studies and a plausible hypothesis for how cells are expected to improve a disease process.
Yamanaka added, “We stress the importance of regulatory oversight at many stages in the development of new stem cell therapies, and the testing of these therapies in controlled clinical trials to generate knowledge that can help all patients.”
Read the official statement by the European Medicines Agency (EMA).
Added May 3, 2013: Read the Commentary published by the EMBO Journal:
Bianco, P., et al. (2013). Regulation of stem cell therapies under attack in Europe: for whom the bell tolls. dpi:10.1038/emboj.2013.114
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The International Society for Stem Cell Research is an independent, nonprofit membership organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, to encourage the general field of research involving stem cells and to promote professional and public education in all areas of stem cell research and application.