May 29, 2020

The Niche

Knoepfler lab stem cell blog

fat stem cells

6 min read

Right now the FDA has a big fat stem cell conundrum on its hands. The agency is faced with a tough dilemma as how to deal with fat (adipose) stem cell products and the large number of businesses who sell them. Are fat/adipose stem cells a drug or not? If yes, what does the FDA do about the hundreds of clinics currently marketing them without approval? If not, then how does the agency reconcile that with its past statements and even words this year under …Read More

2 min read

A patient in Japan has reportedly filed suit against a fat stem cell clinic and has won a judgement of 1.84 million yen in total (about $15,000 USD). The Tokyo District Court reportedly ruled in favor of the patient and most of the award is reimbursement. Authors Ikka, et al report on the case and changes in Japanese law overseeing regenerative medicine in a new Cell Stem Cell piece. The Mainichi reports that the female patient sought treatment from the stem cell clinic for “numbness …Read More

2 min read

Remember good old Celltex? That’s the Texas stem cell clinic with the famous patient, former Texas Governor and two-time GOP Presidential hopeful, Rick Perry. It ran afoul of the FDA and headed for the border, setting up shop in Cancun, Mexico. They have since mostly flown under the radar with the exception of their concerning partnership with the US Arthritis Foundation and their PR about a pediatric patient. More recently they are bubbling up again with more focus on their patients. For instance, they are …Read More

3 min read

The FDA released more draft guidance with strong relevance to the stem cell field. This October 2015 new draft guidance follows about a year after three other previous draft guidances that made it clear the current FDA thinking on various issues including stromal vascular fraction (SVF; fat stem cells) was much more restrictive than generally thought in the for-profit stem cell clinic field. “Industry” apparently hasn’t been happy about this. For instance, December 2014 FDA draft guidance very clearly indicated that fat-related stem cell products …Read More

2 min read

For years I’ve been writing about fat stem cell clinics that sell non-FDA approved stem cell “treatments” to vulnerable patients right here in America. These clinics have been sprouting up like mushrooms across the US and their numbers may be above 200 today overall. As a result perhaps it was inevitable that one would arrive in a locale near me. Tomorrow, July 11, reportedly the Irvine Stem Cell Treatment Center will open a Sacramento, CA branch. The doctor there will apparently be Thomas A. Gionis (picture …Read More

6 min read

Is it the beginning of the end for dubious American clinics that sell transplants of unproven and non-FDA approved fat stem cell injections? As the year of 2014 was winding down, the FDA issued two key new draft guidances (see here and here) that could prove to be crash diets for these burgeoning fat stem cell clinics. (Update: As of 2020, the FDA has now clearly defined fat stem cells as drug products and filed suit against two firms marketing unapproved fat stem cells.) These new FDA guidances indicate …Read More