ISCT Commends the Recent FDA Injunctions Against US Stem Cell Clinics
Friday, May 11, 2018
Cell and gene therapy represent a significant opportunity to address unmet medical needs in several fields of medicine today. In fact, several products have been recently approved, after due demonstration of their risk-benefit proposition with documented benefits. Many more are currently undergoing clinical trials in order to generate adequate information that supports their future use, once approved by regulatory authorities, for the proper benefit of patients. Despite that, several organizations persist in exploiting the hope of patients in difficult situations by providing unproven and dangerous stem cell therapies.
ISCT applauds the recent action of the FDA in seeking an injunction against two stem cell clinics in line with recent announcements and public positions by the FDA against the use of unproven cell therapies. The manipulation of patients' expectations by promising unproven effects and the jeopardy of patient safety by the non-compliance with production and administration regulatory requirements needs such legal action as the one now taken by the FDA.
The mission of ISCT is to promote the development and access of adequately manufactured and documented cell and gene therapies to patients. This has been clearly demonstrated at the recent ISCT 2018 Annual Scientific Meeting in Montréal, Canada where multiple stakeholders, including patients, patient associations, the FDA and innumerous investigators, discussed the topic of unproven cell therapies alongside the excitement and recognition of the emerging multiple cell and gene products in development or already in the market.