Three recent media pieces on unproven, for-profit stem cell clinics paint an unflattering picture of this industry. At the intersection of these pieces is the clinic “treatment” consisting of fat stem cells (being manufactured as in a screenshot at right from a clinic YouTube video), a product the FDA has indicated is most often going […]
New stem cell clinic insights from trio of critical media pieces Read More »
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
Sen. Grassley asks tough questions for FDA on U.S. Stem Cell, blinded women Read More »
Do stem cells for vision loss offer real hope? I believe so, but it’s a long road and must be done right. A new paper in this area generated some buzz on top of an earlier recent pub (mentioned in this post) just a week or so ago about the potential of stem cells for vision
Perspectives on new stem cells for vision loss paper Read More »
How far will stem cell clinics go to market their non-FDA approved “treatments” that they often claim will have miraculous results? I’ve never seen anything quite as striking as what some clinics in the Seattle area are now doing. In the past, we’ve seen clinics take researchers’ pictures, quotes, or videos to use for their
Seattle clinic uses FDA commish in marketing non-FDA approved stem cells Read More »
The FDA issued a historic statement today promising to more clearly define its regulatory policies on stem cell therapies and to take strong action on some stem cell clinics that it views as “bad actors”. I’ve never the FDA use such clear-cut language before. I give big kudos to new FDA Commissioner Scott Gottlieb. It already
Six questions as FDA takes new shot at stem cell clinics Read More »
This edition of our stem cell news bites finds a number of notable stem cell news items. A potentially cool link between gut stem cells and microbiota is reported by Tae-Hee Kim of the Ontario Institute for Regenerative Medicine. See the nifty image of the stem cells from Dr. Kim showing proliferating gut cells in
Stem cell news bites: microbiota, clinic doc death, Stem Cells Inc, & more Read More »
The FDA in the past year or so has issued draft guidances on regulation of stem cells that would, if finalized, make it crystal clear that what many American stem cell clinics are selling are unapproved drugs. That would be a good thing for patients who are often being put at risk by many of
FDA meeting on stem cell regs: mostly who’s who of anti-regulation forces Read More »
Last week I blogged about how the FDA had issued a warning letter to a series of three co-owned fat stem cell clinics across the US. What does this FDA action mean on the broader stem cell clinic arena, particularly to those selling fat stem cells? The FDA is still in the process of getting public comment
FDA warning points to tougher regulation of fat stem cells & clinics Read More »
The FDA has sent a Warning Letter to the Irvine Stem Cell Treatment Center. The leader of Irvine Stem Cell Treatment Center is Dr. Thomas Gionis and the letter was addressed to him. Interestingly, this letter, dated December 30, 2015, contains redactions. At one time this clinic was part of the larger Cell Surgical Network (CSN)
FDA Warning Letter to Irvine Stem Cell Treatment Center Clinics Across US Read More »
Each year around this time I check up on my past year’s predictions for the stem cell field. For 2015 I made 20 predictions. You can see past 10 predictions lists for 2013 and 2014. It’s pretty interesting to look back at where the focus was in past years and what my crystal ball yielded
How did my 20 stem cell predictions for 2015 fare? Read More »