fat stem cells Archives - Page 2 of 4

When the fat stem cells hit the fire, will clinics sued by FDA opt to stop soon?

May 22, 2018 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Will the adipose stem cell clinic firms facing permanent injunction suits by the FDA — U.S. Stem Cell Inc. (USRM) and California Stem Cell Treatment Center (CSCTC)/Cell Surgical Network (CSN) — cool it in the sense of voluntarily shutting down their commercial fat stem cell injections of customers soon pending the outcomes of the suits? […]

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Clinic biz US Stem Cell reports SEC subpoena, adding to uncertainty on its future

April 22, 2018 / Professor Paul Knoepfler, Ph.D. / 7 Comments

The last few years for the publicly-traded stem cell clinic biz, US Stem Cell, Inc., which goes by the ticker $USRM, have seemed like a rollercoaster to me as an observer. I can see four main areas of news that to me make the future seem uncertain for this firm. First, the US Stem was linked to the

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Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women

April 16, 2018 / Professor Paul Knoepfler, Ph.D. / 16 Comments

stem-cells-eyes, stem cell therapy side effects.

Early in 2016, we started hearing about patient allegations of having been blinded in Florida by at least one stem cell business and several allegations seemed linked to a publicly-traded company called U.S. Stem Cell, Inc. (USRM). In turn, there have been a number of lawsuits involving USRM, including one filed just a few months

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FDA Issues 1st Stem Cell Warning Letter of 2018 to American CryoStem

January 7, 2018 / Professor Paul Knoepfler, Ph.D.

The FDA started off 2018 with a bang on the direct-to-consumer stem cell clinic front with a warning letter on January 3rd to American CryoStem, a firm involved in processing and distributing adipose stem cells. The company’s ATCELL™ adipose stem cell product was the focus of much of letter. The FDA indicated in the warning

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Dissecting the FDA’s big, fat stem cell dilemma

September 26, 2017 / Professor Paul Knoepfler, Ph.D. / 18 Comments

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

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‘Are fat stem cell clinics selling unapproved drugs?’ reporters ask in talking about our new paper

July 3, 2016 / Professor Paul Knoepfler, Ph.D. / 18 Comments

Our new paper in the journal Cell Stem Cell on the large stem cell clinic marketplace in the U.S. documented a wide range of different kinds of clinics, stem cells used, and conditions claimed to be treated, but here I want to focus on the fat stem cell clinics in this post. I’m going to try

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Woman’s death after “no big deal” fat stem cell therapy: coroner investigating

June 20, 2016 / Professor Paul Knoepfler, Ph.D. / 20 Comments

An elderly woman in Australia reportedly died shortly after receiving a fat stem cell transplant. Sheila Drysdale passed away hours after getting an adipose stem cell treatment a few days before Christmas in 2013. That death is now being investigated by the coroner there. Not only is this death in Sydney distressing in it of

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Patient Sues Fat Stem Cell Clinic & Wins

November 9, 2015 / Professor Paul Knoepfler, Ph.D.

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

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Tex-Mex Stem Cell Clinic, Celltex, on PR roll with young & famous patients

November 6, 2015 / Professor Paul Knoepfler, Ph.D. / 1 Comment

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

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More tough FDA draft guidance on stem cells…still no action

November 5, 2015 / Professor Paul Knoepfler, Ph.D. / 33 Comments

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

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