January 25, 2021

The Niche

Trusted stem cell blog & resources

Report on day 2 of FDA stem cell meeting: patients, researchers, & more

The FDA’s stem cell meeting wrapped up today on day two with a diverse group of individual speakers. A series of patient testimonials today in favor of clinics was one thing that stood out. You can read my take of day one and the account of Jeanne Loring who was at the meeting. I’ve noted that on average about 350 people were watching the webcast of the meeting both days.

Screen shot from FDA stem cell meeting webcast

The patients gave powerful, often emotional testimonials today on their experiences at various stem cell clinics including Celltex and most prominently Stemgenex. I think there were 7 of its patients who spoke. I have no doubt of the patients’ sincerity in their belief that they’ve been helped.

Various stem cell clinic doctors also testified.

As with yesterday, a common statement was that there are “no side effects” of stem cell treatments, which is concerning as all medical therapies have some risk of side effects.

A number of health care practitioners and researchers voiced support for the FDA and its draft guidances. For instance, nurse practitioner Sheila Sabon DeCastro did an especially outstanding job at articulating the urgent need for the draft guidances to be finalized.

Jeanne Loring gave a talk regarding both stem cell clinics as well as her own clinical research to develop IPS cell-based products for Parkinson’s Disease. She did a great job.

Bioethicist Leigh Turner talked about the stem cell clinic marketplace in the US today including discussing our work together that we recently published in Cell Stem Cell on the astounding number of stem cell clinics in the US at this time. He was supportive of the FDA draft guidances and commended the agency for them.

However, Leigh was also critical (rightly so I believe) of the lack of appropriate FDA oversight of stem cell clinics recently and noted this inaction’s likely contribution to the growth of the stem cell clinic industry. For instance, Leigh mentioned that he contacted the FDA three years ago about specific clinics that concerned him, but that those clinics still operate and the FDA apparently has not done anything.

He ended with a very assertive concluding paragraph:

“The out-of-control marketplace for stem cell interventions needs effective regulatory oversight. I therefore hope the draft guidances are more than stage props and this hearing is more than public theater. When patient safety and public health are at stake, the FDA must do more than function as a paper tiger. It is time for action.”

It is time for action or who knows where things will be a year or two from now. A thousand clinics in the US administering unproven stem cell products to hundreds of thousands of patients?

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