What to Know Before Treatment
When considering a cell therapy treatment, it's important to understand how your treatment will be administered and ensure the provider is well-qualified.
Stem Cell Therapy Warnings
When considering a cell therapy treatment, it is important to understand how your treatment will be administered and ensure the provider is well-qualified. Stem cell clinics have popped up around the world, touting 100% success, however, in many cases these experimental treatments have yet to be evaluated by the FDA (Food & Drug Administration) or other regulatory agencies in their countries of origin.
The FDA warns patients to take caution with unregulated stem cell therapies. Reputable centers, including the MSCTC, are working with the FDA to develop regulations that protect the health of the patient and hold providers to high standards of treatment. Without these regulations in place, unqualified providers may endanger patients' health.
For example, as in organ transplants, patients who receive stem cell therapy are at risk of their immune system rejecting the transplant. To avoid this, immune system-suppressing drugs must be taken. Further, if stem cells are not manipulated correctly, the receiving patient can be exposed to bacteria, fungi or viruses which have been picked up during the manipulations of the stem cells, or, in some cases, receive cells that are not appropriate for use in treating a specific injury or disease.
Questions to Ask
If you're considering stem cell therapy treatment in the United States, proceed cautiously. Ask your physician questions and be comfortable with the procedure and risks before accepting treatment. Consider asking these questions:
- Is the therapy reviewed or approved by the FDA or part of a clinical trial? The FDA approves therapies after appropriate testing. To participate in a clinical trial, you must sign a consent form. The consent form also identifies the Institutional Review Board (IRB) that assures the protection of the rights and welfare of human subjects. Please visit ClinicalTrials.gov, a database of privately and publicly funded clinical studies conducted around the world to review clinical trial information.
- What is the procedure? Ask for details, including a need for immunosuppression, hospitalization, other drugs/treatments or repeat treatments.
- What is the source of the cells and/or biological molecules? What is being injected?
- What is the training and licensing of the physician? What is the safety record of the physician and clinic? Do they have a familiarity with the scientific literature?
- Are there any previous results with this procedure? How many have been treated? Is there any publication of this or similar work? (You should require more than claims and testimonials.)
- What are the potential outcomes and risks, including adverse reactions?
- What are the alternative treatments?
- What are the costs, including breakdown of items? If it is a research trial, am I expected to pay for it?
- Is a follow-up visit required?
If you are considering treatment in another country, learn about international regulations that cover products in that country.