Regulators, Legislators Taking Action on Unproven Stem Cell “Treatments”

December 6, 2017

The scientific and clinical communities have long been troubled by clinics operating around the world that market unproven stem cell “treatments” directly to patients.

It is particularly distressing that people often go to these clinics for relief or a cure for an intractable disease or injury, and can end up paying thousands of dollars for products that are not approved for use as advertised, have not been scientifically tested to know if they work, and can put their health in jeopardy. This includes procedures using the patients’ own stem cells (aka autologous use), which can also carry with it tremendous risk, even death. (See earlier blog post: Stem Cell Soup: The Importance of Knowing What Is In It).

Fortunately, several jurisdictions around the world are beginning to pay attention to the activities of such clinics. Efforts are underway to hopefully stop clinics from peddling risky stem cell treatments, and help patients by providing clear information about whether advertised stem cell products are safe and proven to work.

Regulatory Efforts in the U.S.

Recently, the U.S. Food and Drug Administration (FDA) announced enforcement actions against two clinics: it seized unapproved products from StemImmune Inc. of San Diego, California, and issued a warning letter to the U.S. Stem Cell Clinic of Sunrise, Florida. Both were providing “unapproved and potentially dangerous” stem cell interventions that put patients at risk. In the announcement, the FDA commissioner stated that the agency “will take a firm stance against those that prey on the medical promise of regenerative cell therapies to market treatments potentially unsafe or unproven so-called cures.”

The FDA also recently announced new regulatory and enforcement measures meant to more clearly define stem cell treatments that require agency oversight. The ISSCR, which has long advocated for such a move, issued a statement of support, noting that the agency will need additional resources to enforce the new rules effectively for the protection of patients.

Outside the U.S.

In Australia, the government announced it too will change regulations regarding the use of autologous stem cell interventions—those that are removed from a patient and then re-applied to that same patient. While those treatments had not previously been regulated, they are now brought into the regulatory regime, thanks in part to news reports such as this one that clearly describe the risk involved for patients.

Health Canada also communicated to reporters that it will begin  reaching out to private Canadian clinics that sell unproven stem cell interventions, many of them autologous, to verify they are in compliance with the Food and Drugs Act in Canada. [Health Canada has only approved one stem cell treatment for clinical use]. 

India also appears to be tightening up oversight of stem cell-based interventions, with the release of National Guidelines for Stem Cell Research that come down strongly against unproven uses of stem cells. They admonish that “…every use of stem cells in patients outside an approved clinical trial is unethical and shall be considered as malpractice.”

New Legislation in California

These activities have not been limited to national regulatory agencies. A law passed in California in October requires clinics to inform patients if they are using stem cell interventions that have not been approved by the FDA. Clinics will be required to post a notice in their office, and provide handouts to each patient, stating that the procedure has not been approved for clinical use.

Ensuring Stem Cell Products are Safe

As potential therapies are developed in the lab, and then made into products for medical use, they require careful review and testing to ensure they are safe AND effective.

This Closer Look at Stem Cells site includes accurate, scientifically vetted information about the potential of stem cell medicine, and its current limitations. If you or a loved one is considering a stem cell treatment, review the ‘Stem Cells & Medicine’ section to learn more about what is known, and how to approach your physician with questions, before moving forward with any stem cell procedures.