FDA seeking to stop procedures at two unregulated stem cell clinics

Federal health officials filed Federal injunctions Wednesday to stop two clinics from continuing to offer unproven stem cell therapies to patients, the most aggressive action taken in years. Two clinics — US Stem Cell, based in Florida, and California Stem Cell Treatment Center — were warned by the FDA in August that they had violated manufacturing procedures.

FDA seeking to stop procedures at two unregulated stem cell clinics – STAT

At US Stem Cell, a 2015 procedure led three women to go legally blind, California Stem Cell Treatment Center was involved in making an experimental cancer treatment from smallpox vaccine without any oversight. Another corporation (with over 100 clinics) Cell Surgical Network will also be affected by the CA injunction.

This issue has been building since Celltex, a Houston-based company received an FDA warning letter in 2012 because they were manufacturing stem cells without approval or inspection, not just mixing and administrating them (what clinics are allowed to do). Something called a BLA is needed to make a biologic drug (what stem cells are).

Next, they went after other clinics doing the same things (making products): Irvine Stem Cell Treatment Center, Miami Stem Cell Treatment Center, and Manhattan Regenerative Medicine Medical Group. As they investigated, the scope of the problem just kept building. Arriving at a Federal injunction (let alone two) takes a long time and a lot of evidence for an agency; the bar is set high to prevent government overreach.

Watch it with the stem cell therapies, folks. I know there’s a lot of excitement out there because of all the possibilities. Just because the proprietors of those clinics say they are within their legal rights and licensing to offer whatever therapies (and products) they see fit, does not make it necessarily so. Compounding pharmacies got into a whole lot of trouble (and killed and sickened a whole lot of people) a few years back for the same types of sloppiness and assumptions. Money and greed can induce people to do bad things; even doctors, even when a product is very cool and promising.

Duped patients crowdfund for bogus medical care

As stem cell scientist Paul Knoepfler puts it: “You should start getting worried if the clinic tells you that one kind of stem cell such as fat, bone marrow, or amniotic stem cells can treat many different conditions. There’s no science behind that kind of claim. Stem cells are not a panacea.”

If you’re truly interested in the evolving science and compliance behind all of this, here is some information.

Products under scrutiny: fat stem cells (adipose stem cells) and stromal vascular fraction (SVF).

In response to the fast pace of evolution on all things cell-based therapy, FDA created a Regenerative Medicine Policy Framework  they have issued several ‘guidances’ related cell-based therapies. There is one ‘draft guidance’ focused on commercial stem cell clinical products. Don’t listen to the folks with twenty-year-old gripes about how FDA doesn’t care about sick people or is in the pockets of industry. No large government agency is perfect or is completely immune to the industry they serve.

Some good sources of education:
Stem Cell Assays: Promoting Rigorous Reproducible Research on Stem Cells

The Niche: Knoepfler Lab Stem Cell Blog   SCOPE: What Are Stem Cells?

 

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