Since there is no scientific basis for their treatments, the clinics use patient testimonials and patient ratings to give the illusion that there is a medical benefit to their activities. The testimonials say that the patients are satisfied, they trust the organization, and they would recommend the treatment to others. But this is not science, and these are not verifiable clinical milestones and outcomes. This is advertising.
It is important to understand the role of the FDA in regulating stem cell therapies at these clinics. The FDA has made it clear that two characteristics of a stem cell treatment make it subject to FDA regulations. First, any manipulation of a harvested tissue (separation of cells from fat or culturing or concentrating bone marrow cells) gives the treatment status as a drug. Second, taking cells from one location (such as fat) and putting them into another location, such as the bloodstream, also means that the cells must be regulated as a drug.
The FDA has been slow to enforce their oversight of these clinics by any meaningful action, and this regrettably has, if not condoned, permitted the proliferation of sites offering perceived unregulated stem cell treatments. But happily this is changing. At the World Stem Cell Summit in 2015, Robert Califf, M.D., the FDA Commissioner, told the gathering of scientists, clinicians, and patient advocate attendees that the FDA is willing to consider complaints about any specific clinic. The contact information is here: http://www.fda.gov/AboutFDA/ContactFDA/
There is another opportunity to let the FDA know our opinions. In September, the FDA will hold a public hearing on their proposed changes to regulations of stem cell therapies3. This meeting, called “Part 15 Hearing on Draft Guidances Relating to the Regulation of HCT/Ps [Human Cells, Tissues, and Cellular and Tissue-Based Products],” will be held at the NIH headquarters in Bethesda, MD. There are 54 clinics or organizations scheduled to speak at this meeting and forty individuals. All of the speakers will have 5 minutes. One of us (Loring) will speak on September 13 (2:34-2:39 pm).
What else can be done? Since the public is the victim of these clinics, anyone invested in the development and implementation of legitimate therapies must get involved to curtail these opportunists whose money-making ventures not only may be harmful but jeopardize by association the real potential of stem cell research in regenerative medicine. Previous attempts to expose such clinics have been if not silenced at least muffled by the threat of legal action. We in turn need to turn to the law to safeguard the future of regenerative medicine.
Clinics often make patients sign agreements not to disparage them as a condition of providing the treatment. This makes it difficult for individuals to sue the clinics for failing to provide a therapy that has the positive effects advertised, though there has already been a precedent. A product liability lawsuit has been filed against one such U.S. clinic4. The high costs of these treatments, from $10,000 to $100,000, should motivate individuals seeking these therapies to ask for some guarantee or at least the right to seek recourse in the event of harm or non-provision of goods as promised.
The public has a major role to play in the protection of regenerative medicine. After all, who has a greater stake in the responsible advancement of the field?