When people discuss “fat stem cells” they usually mean “stromal vascular fraction” or SVF. While references to fat or adipose stem cells can sometimes mean non-SVF materials, these days adipose SVF gets the most attention. But, does anyone have a clear picture of this biologic? Fortunately, it’s starting to come more into focus in recent years […]
What is stromal vascular fraction or SVF? Read More »
A big, fat elephant in “the room” of the commercial stem cell field today is something called stromal vascular fraction or SVF, made from human fat tissue or adipose. If you care at all about stem cells or the stem cell field more generally, you had better educate yourself on SVF. You can learn a
Law and Order SVF: what is stromal vascular fraction? Read More »
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 »
An important appeals case is pending not just for the defendants Cell Surgical Network, et al., but also for the FDA. It could impact the stem cell field very broadly too. Cell Surgical Network lawsuit status Hopefully, we’ll get a decision before the end of this year. Cell Surgical Network is a large chain of
Goldwater Institute weighs in against FDA on Cell Surgical Network lawsuit appeal Read More »
It feels like I’ve been writing about the Florida clinic US Stem Cell for a very long time. The FDA has been aware of them for about as long. It was only after reports of patient injuries that the FDA at last took action on US Stem Cell and its subsidiary US Stem Cell Clinic. Several
Did US Stem Cell Clinic defy FDA injunction? New injured patient suit sparks questions Read More »
Toward the end of each year, I make stem cell & regenerative medicine predictions for the coming year. It’s a fun tradition here on The Niche that goes way back. The stem cell field has changed dramatically as reflected in each year’s predictions. Here’s a list of past predictions with my grades of how they
2023 stem cell & regenerative medicine predictions Read More »
The FDA has finally filed an appeal of the Cell Surgical Network lawsuit verdict. It took them a very long time for some reason. The stem cell clinic chain Cell Surgical Network and other defendants had prevailed in a federal district court here in California in front of Judge Jesus Bernal. Their adipose cell product, stromal
FDA appeals Cell Surgical Network lawsuit verdict Read More »
In a ruling that could turn FDA stem cell clinic oversight on its head, Federal District Court Judge Jesus Bernal last night ruled in favor of the stem cell clinic chain Cell Surgical Network and other defendants. The FDA had been seeking permanent injunction against them. Here’s the court ruling. Drs. Mark Berman and Elliot
Judge drops a bomb on FDA in Cell Surgical Network stem cell clinic case Read More »
Over the past dozen years as I’ve written about stem cell clinics here on The Niche I’ve gotten to know many of those running the clinics including Dr. Mark Berman of Beverly Hills. It was therefore kind of a shock to learn that Berman died of last month. Michael Hiltzik of the LA Times reported
Thoughts on death of stem cell clinic leader Dr. Mark Berman Read More »
A stem cell clinic in the Cell Surgical Network chain has just been sued allegedly for causing vision loss in a patient. By my count, across the U.S. this makes at least 5 patients who have said they were either totally blinded or had some major vision loss after getting stem cells injected into their
New suit for vision loss against Cell Surgical Network clinic Read More »