Search Results for: fda

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

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Robert Califf, FDA Commissioner

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 […]

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Recommended reads: FDA warning on stem cells for pets, chromatin, aging & HSCs

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Safari Stem Cell, stem cells for pets

When I first saw the new FDA warning on stem cells for pets and the logo for the company that received it, I was surprised in a few ways. I don’t recall ever seeing such a letter and the logo is something else. We’ll get into all of that in a moment, but first, since

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

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SVF

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

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Q&A with Kyle Cetrulo of The Perinatal Stem Cell Society on the FDA, state laws, & more

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Kyle Cetrulo, Perinatal Stem Cell Society

I was interested to see that an organization called The Perinatal Stem Cell Society seems to have been upbeat about the new Utah stem cell law. That law sets up a likely conflict with the FDA and federal law over stem cells. In a nutshell, Utah now says you can sell non-FDA-approved stem cells in

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Utah stem cell law OKs non-FDA approved placental cell drug therapies likely sparking conflict

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Utah Rep. Katy Hall

Utah appears ready to pass a new stem cell law that would explicitly allow clinical use of non-FDA-approved placental cell drug therapies in the state. Bill 199 seems likely to set up a conflict with the FDA that may land in court. The key part of the bill says: “A health care provider whose scope

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9th Circuit hearing on FDA appeal of Cell Surgical Network case: maybe encouraging?

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Cell Surgical Nework

I was able to watch some of the 9th Circuit Court hearing today on the FDA appeal of its loss in the Cell Surgical Network lawsuit. This post is my brief impressions as a scientist. What went down? Do the three judges seem to be leaning one way or another? The ruling in this case

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Weekly reads: MiMedX & Kimera Labs FDA warnings, NYT on Bryan Johnson, MUSE cell trial

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AXIOFILL, MiMedx

Placental biologics firm MiMedx and exosome company Kimera Labs both recently received FDA warning letters. The letter to MiMedx was related to its placental biologics products and procedures. The new warning to Kimera Labs was about its exosome products and an amniotic product. Let’s compare these letters starting with the one to MiMedX. MiMedx warning letter

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Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics

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AABB, FDA

The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges,

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Weekly reads: FDA OKs 2 gene therapies for sickle cell, new Paolo Macchiarini series, Fujifilm

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Marie Tornyenu, Casgevy gene therapies for sickle cell

The big news broke Friday that the FDA approved two new gene therapies for sickle cell disease. While the approvals were expected and the actual use of these treatments will be complex on several levels, this is a historic development. 2 FDA-approved gene therapies for sickle cell Friday’s news follows on recent UK approval for

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FDA warns Neil Riordan U.S. perinatal firm Signature Biologics

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Signature Biologics, Neil Riordan

Neil Riordan may be most well-known for running the Panama stem cell clinic called simply enough the Stem Cell Institute, but he also has a U.S. firm Signature Biologics. The Panama  clinic sells unproven umbilical cord cells grown in a lab for a host of medical conditions. I’ve had many concerns about it over the

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