You searched for stem cells clinics

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? […]

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

Cell Surgical Network, largest group of US clinics, using lab-expanded stem cells in patients?

February 15, 2017 / Professor Paul Knoepfler, Ph.D. / 19 Comments

Is the largest affiliated group of stem cell clinics in America, Cell Surgical Network, now using laboratory-proliferated stem cells in patients? Do they already have some kind of final FDA approval for this clinical approach given that lab-grown stem cells are generally viewed as drugs requiring premarket approval? Over the years I’ve reached out to

Cell Surgical Network, largest group of US clinics, using lab-expanded stem cells in patients? Read More »

Wanted both dead & alive: amniotic stem cell clinics sell zombie cells?

December 22, 2016 / Professor Paul Knoepfler, Ph.D.

Some amniotic stem cell clinics seem to be trying to have their cake and eat it too. Generally the amniotic stem cell clinics market their products as “stem cells” and the implication is that living stem cells are used to effectively treat many medical conditions. I have not seen it mentioned that what some of

Wanted both dead & alive: amniotic stem cell clinics sell zombie cells? Read More »

FDA warning points to tougher regulation of fat stem cells & clinics

January 24, 2016 / Professor Paul Knoepfler, Ph.D. / 10 Comments

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 »

Lung Institute stem cell clinic loses class action suit, patients awarded $9M

July 2, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

Remember the Lung Institute? Many patients raised red flags about their experiences there. It was also once known as the Lung Health Institute. More generally, patients who have been harmed by stem cell clinics have had to rely on other ways beyond the FDA to try to do something about it. The FDA has been

Lung Institute stem cell clinic loses class action suit, patients awarded $9M Read More »

Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem

June 26, 2024 / Professor Paul Knoepfler, Ph.D. / 4 Comments

FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I

Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem Read More »

Mostly discouraging trial of MSC-NPs or purported neural cells from MSCs for MS

June 11, 2024 / Professor Paul Knoepfler, Ph.D. / 2 Comments

The idea of mesenchymal cells or MSCs for MS has been around for a long time. However, there haven’t been that many strong clinical trials testing it. There’s a new paper out that reports one of the stronger MSC-related trials for MS in terms of design. In this case, they didn’t use just MSCs but

Mostly discouraging trial of MSC-NPs or purported neural cells from MSCs for MS Read More »

Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society

June 4, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

Perinatal Stem Cell Society email material.

I recently interviewed Kyle Cetrulo of the Perinatal Stem Cell Society. This organization seeks to catalyze big changes in stem cell use and clinical trials in the U.S. In the interview, we touched on many topics including FDA oversight of the cell therapy space. Some of this discussion was in reaction to the new Utah

Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society Read More »

Recommend reads: FDA SVF warning, big Aspen grant, CSI finale invokes stem cells

May 26, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

One of the most contentious areas in the regenerative medicine arena is whether a fat tissue product called stromal vascular fraction or SVF is a drug. The FDA says SVF, even in autologous form, is a drug. It is seeking an injunction against a California-based network of SVF clinics but lost the initial case. That

Recommend reads: FDA SVF warning, big Aspen grant, CSI finale invokes stem cells Read More »

Search Results for: stem cells clinics