You’ve probably seen the ads or the comments on Facebook or blogs: “You should try stem cell therapy for your COPD. It worked for me.”
There are two reasons to be careful about seeking stem cell treatment for your COPD.
Stem Cell Therapy for COPD Is Not A Proven Treatment
First, stem cell therapy has not been proven an effective treatment for COPD. While we’re not saying that it will never be effective, like many therapies under development, it deserves study. But for now, it is unproven.
There Are Bad Actors In the Stem Cell Clinic Field
Second, there are a number of bad actors in the field; unscrupulous outfits that are administering stem cell treatments to patients either without FDA approval or without adhering to standards of procedure that ensure sterility of the product being administered. At best, patients at these clinics are subjecting themselves to procedures that will not work for them; they are spending money on false hope. At worst, patients are being exposed to bacterial infections and other side-effects that could cause them serious risk; they could be made more sick than they already are.
Here are two examples in point:
US Stem Cell Clinic
The US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, announced in August that the FDA sent a warning letter to US Stem Cell Clinic of Sunrise, Florida for marketing stem cell products without FDA approval, and for failing to adhere to good manufacturing practice requirements, which could affect the sterility of their products. Needless to say, both of these factors put patients at risk.
US Stem Cell Clinic was manufacturing its own stem cell product from adipose tissue and administering it either intravenously or directly into the spinal cord of patients to treat a range of conditions, including COPD. The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use. In addition, the clinic was found to have failed to establish and follow appropriate written procedures to prevent microbiological contamination in at least 256 lots of stem cell products.
The FDA announced also that it took action to prevent the use of a “potentially dangerous and unproven treatment” at centers in Rancho Mirage and Beverly Hills belonging to StemImmune Inc of San Diego, California. The US Marshals Service seized five vials of live virus vaccine at their centers, a vaccine that is reserved for people at high risk for smallpox and is not commercially available. The FDA is now investigating how the clinic obtained those vials.
New FDA Oversight of Stem Cell Centers
Dr. Gottlieb noted that these two centers are examples of a larger pool of centers that claim that their unproven and unsafe products will treat a serious disease, but that instead put patients at significant risk. “We will seek to take additional actions in the coming months as we address this field, and target those who are clearly stepping over the line,” he said. At the same time, he noted, the FDA is developing a comprehensive and efficient science-based policy to accelerate the proper development of stem cell therapies.
Details of the new FDA policy will be announced this fall.
Information for this article was obtained from Medscape.