Search Results for: amniotic and cord blood

End of FDA “grace period” impacted perinatal cell therapy biotechs

knot in umbilical cord, perinatal cell therapy

If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in …

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FDA news: warning letter pattern, cancer moonshot, CAR-T & gene-editing guidance

FDA-draft-guidance

The FDA has been busy with the COVID pandemic but it has many other things on its plate as well including cell therapies. Today I’m sharing some recent agency news and brief perspectives on it. FDA focus on clinic-related umbilical cord cell drug makers The agency warned an Idaho company that produces and sells umbilical …

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What is Wharton’s jelly & its possible clinical uses?

Wharton's jelly umbilical cord H&E

For more than a year in my first job as a scientist I isolated cells from umbilical cord veins and then tossed the tissue away, never realizing there was more there that could be useful in the form of something called Wharton’s jelly. What’s in this article Umbilical cord histology & Wharton’s jelly | What …

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2 State AG’s sue ‘Stem Cell Centers’ clinics including for alleged fraud

Travis-Autor

Some readers suggested earlier this year that I look into a clinic firm called ‘Stem Cell Centers’ with its owner Travis Autor. I didn’t have time to do much since I’ve been very busy in the lab before the state Attorney Generals of Iowa and Nebraska sued them based on a number of allegations including …

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Historic spring storm of FDA letters to stem cell clinic industry

FDA-letter-stem-cells

The FDA has stem cell clinics squarely on its radar screen now and it’s pulling the trigger with many letters going out to this problematic industry. In the past, sometimes years went by with no letters at all or one letter in total to stem cell clinics so this marks a major shift. Background on …

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As clinics buzz about coronavirus, COVID19 patient given non-FDA-approved exosomes?

Kimera-Labs-exosomes-COVID-19-novel-coronavirus-disease

When the number of stem cell clinical studies and trials listed for COVID-19 first started spiraling upward it seemed likely that stem cell clinics and other firms in that arena would get interested. I thought that we’d see the unproven regenerative medicine coronavirus bandwagon quickly grow. Unfortunately, there are reasons to be increasingly concerned here. For instance, …

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‘Captain Kirk’ regenerative clinic supplier Invitrx gets long FDA warning letter

Habib-Torfi

Should we call it stem cell synchronicity for stem cell supplier firm Invitrx? What was it about March 16? Sometimes strange things happen in the stem cell world such as last week on March 16 I wrote that the FDA needs to do more about unproven exosomes, and then on the same day a new FDA warning …

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Patients stem cell Q&A#1: can clinic injections cause GVHD?

Colonic_graft-versus-host_disease-GVHD

People ask me questions about stem cells all the time so I decide to do a new blog series answering your questions. Today’s post is  the first in this new stem cell Q&A series. Past series have included my Elephant in the Lab series that provides some insights into the craziness that sometimes goes on …

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Muddy waters: stem cell clinic calls itself CIRM & docuseries sparks controversy

CIRM-or-CIRM

We’re seeing more muddy waters in the stem cell universe. A chiropractic stem cell and alternative medicine clinic has popped up calling itself, of all things, CIRM. On another front, an already controversial docuseries set to air tomorrow combines interviews with prominent academic stem cell scientists and unproven stem cell clinic folks, muddying the waters. …

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