Geoff Lomax is CIRM’s Senior Officer for Medical & Ethical Standards
Yesterday, the International Society for Stem Cell Research (ISSCR) sponsored a public webcast titled: Oversight of Stem Cell Treatments. The Webcast used the example of a recent US District Court of Appeals decision to frame a conversation about the appropriate regulation of stem cell therapies. CIRM grantee Lawrence Goldstein of the University of California at San Diego and Margaret Foster Riley of the University of Virginia School of Law discussed the importance of an effective environment for developing stem cell therapies.
With regard to cell-based therapies, Dr. Goldstein alluded to what he called the “colorless liquid problem.” He was referring to the fact that there are many clinics offering stem cell treatments, but it is often difficult for him, or anyone else, to understand what they are offering.
To address this problem, Dr. Goldstein indicated that any such treatment should include:
· A precise description of the cell treatment and how it will be given to the patient
· A mechanism for experts to review the treatment procedure
· A system for collecting data on the performance of the treatment so we can measure how it does over time and with different patients
· Methods for allowing access to data to “contribute to shared knowledge”
· Accountability mechanisms so there is accountability for various claims about the safety and performance of procedures
Dr. Goldstein and Professor Riley emphasized that “good regulation,” such as that carried out by both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), brings these attributes to a system that is flexible and responsive. They emphasized that regulatory bodies are experienced in reviewing information about new treatments for patients, and are committed to getting the best treatments to patients, but they also have an obligation to protect the patients and the public and that means carefully reviewing that information. Members of the public can login to the ISSCR Connect platform to view the archived webcast.
What was interesting about the Webcast is the fact that much of what Dr. Goldstein and Professor Riley emphasized has been incorporated into CIRM’s Alpha Stem Cells Clinic initiative. This program is designed to provide an optimal environment for the development and testing of new cell therapies. The goal is to bring treatments to patients as quickly as possible while ensuring effective safety systems are built into the process. It is great to see CIRM and ISSCR are on the same page.