An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from …
FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics Read More »
Viacord is one of the most well known firms in the for-profit cord blood banking industry. Today’s post is a review of the firm. I see concrete reasons for concern. What is Viacord? | Dubious autism claims | Viacord cost | Overall Review | References What is Viacord? As a cord blood banking firm, Viacord freezes …
Review of cord banker Viacord: dubious autism claims & other concerns 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 »
Cloning is one of those topics that both fascinates and kind of scares people, especially the idea of duplicating people. I regularly cover the topic here on The Niche because stem cell technologies are involved. Also, one form of the process sometimes called “therapeutic cloning” involves embryonic stem cells. Duplicating mammals has now long been …
Weekly reads: freeze-dried cloning, FDA signals, stem cell escapees Read More »
The FDA stem cell clinic problem just continues to grow, while the agency has been oddly quiet in this space for more than a year. It’s been a major disappointment, particularly as in recent years FDA leadership had implied that bold action was coming. Their own words spiked expectations that the agency would tackle unproven …
People are the real driving force in the stem cell and regenerative medicine field including my colleague Jan Nolta here at UC Davis. She is the Director of our Stem Cell Program. There’s also news about Stanford’s stem cell Director Irv Weissman. Jan Nolta receives award Jan’s lab is prolific and in many ways is …
Weekly reads: Jan Nolta recognition, new director after Irv, FDA guidance Read More »
Dr. Paolo Macchiarini exemplifies how things can change quickly in the stem cell world and go from sky highs to deep lows. Stem cell rollercoasters Over the years, a few academic stem cell researchers as well as some operators in the unproven clinic sphere have had dizzying ups and downs. There’s John Kosolcharoen. His company …
Paolo Macchiarini guilty in criminal stem cell case but does a Houdini again Read More »
I’ve had concerns about an American unproven clinic firm called R3 Stem Cell for many years. They sell unproven stem cell-related “treatments” via dozens of affiliated locations. I put quotes around treatments because in my view there is no good evidence here for claims of treating numerous serious illnesses. The goal of today’s post is …
Fact-checking troubling R3 Stem Cell clinic chain Read More »
A few people in the stem cell field keep arguing that adult pluripotent stem cells exist, including so-called “very small embryonic-like stem cells” or VSEL stem cells. These days the supposed cells are called VSELs or V-cells too. Only a handful of researchers have ever been able to report finding and studying these cells. Others …
The Pink Sheet just broke the story that the FDA may change up its oversight of the cell therapy space. This possible shift could drop the oversight bar somewhat for certain products. Most likely it’d be those with lower anticipated risks. The Pink Sheet piece by Sue Sutter is titled US FDA To Explore New Regulatory Pathways …
One size doesn’t fit all? FDA may soften some cell therapy regs Read More »