The ISCT International Society Cell and Gene Therapy has announced its support of the US Food and Drug Administration’s request for injunctions against two US stem cell clinics that have administered unproven cellular therapy treatments to patients.
Approval
“The most recent FDA actions highlight to the entire cell therapy community that the UCT business stretches across the globe, not just in specific regions where regulations are less tight,” said Dr Massimo Dominici, chair of the ISCT Presidential Task Force (PTF) on the Use of Unproven Cellular Therapies (UCT), and professor of oncology at the University of Modena and Reggio Emilia, Italy. “It is vital that regulators, as recently demonstrated by the FDA, continue to identify and shut down clinics conducting unproven and potentially harmful cellular interventions.
“However, all representatives of the ISCT Presidential Task Force agree that the job cannot be left to regulators only. There is no magic bullet for UCT with complex challenges. Patients affected by diseases with a high-unmet medical need have few options. It is up to the cell therapy community to collectively drive more therapies through approval, reduce costs through innovative development and manufacturing strategies and educate the public and patients about the dangers of unproven cellular therapy. As a result, ISCT will continue to coordinate global interdisciplinary efforts to implement these longer-term solutions.”
The action being taken by the FDA was revealed shortly after the ISCT Presidential Task Force Session on the Use of Unproven Cellular Therapies had taken place at the ISCT Annual Meeting in Montreal, Canada. The session, which involved regulators and representatives from academia, industry, bio-ethics and patients, saw discussion on strategies to combat the use of unproven cellular therapy and provided the opportunity to coordinate a joint international strategy.
“Cell and gene therapies are addressing a variety of currently unmet medical needs. Several products have been approved after demonstration of safety and clinical efficacy. Many more are currently progressing through clinical development. However, clinics offering potentially dangerous unproven cell therapies present a significant risk of eroding public confidence in our new, emerging field,” revealed John Rasko, president, ISCTand head, Cell & Molecular Therapies, RPA Hospital, Sydney, Australia. “The FDA action, and wider collaborations at the ISCT Annual Meeting this month, have reinforced the need for ISCT and its members numbering over 1,500 across 50 countries to continue on its mission of promoting the development of, and access to, properly manufactured and documented cell and gene therapies to patients. As these approved therapies are delivered, this will ultimately reduce the demand for unproven treatments.”