Search Results for: stem cell clinics

Burst Biologics unapproved biologic used by Weill Cornell: was there a cover-up?

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Burst Biologics, Christopher Jones

The New York Times just broke a story on Burst Biologics and Weill Cornell that fits with long-standing troubling questions about regenerative biologics producers. The story also bears on the doctors and hospitals like Weill Cornell that were or are customers of the suppliers. Further, what is the FDA’s role in all of this? The […]

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Suit against Dr. Alvaro Skupin & Dra Nancy Alvarez over blinding at clinic is settled

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Dra Nancy Alvarez, Alvaro Skupin

A patient who got scientifically unproven and non-FDA-approved stem cells from Dr. Alvaro Skupin, filed suited against him, his wife who is often known as Doctora Nancy or Dra Nancy Alvarez, and associated businesses. These firms include the stem cell clinic known as Mother Stem Cell Institute in Florida, where the injections apparently took place.

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Weekly reads: HIV from vampire facials, CAR-T, FDA warns Regenative Labs

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vampire facials

Imagine regularly having someone rub your face all over with the equivalent of a small roller covered with spikes and doused with either your blood or someone else’s and you have what’s called vampire facials. There’s more news that this is a very bad idea. Vampire facials linked to more HIV cases “Vampire facials” promoted

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Review of where Kimera Labs fits into sphere of exosome companies

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Kimera labs exosome

Today’s post takes a close look at the exosome manufacturer Kimera Labs in the context of the main exosome companies. What are exosomes? Exosomes are microscopic bubbles or vesicles produced by cells. Exosomes contain many cellular substances that are biologically active. Some of these materials may be helpful clinically, while others could pose risks. Clinical outcomes

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Weekly reads: He Jiankui disappoints, ALS, Vor Biopharma

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He Jiankui

I’m sure many of you remember He Jiankui, the guy who made CRISPR babies. He ended up serving three years in jail in China. He seems to be trying for something of a comeback since his release. Were He Jiankui invitations a mistake? Some prestigious places have even invited him to give talks, which seemed

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Skepticism on the Bryan Johnson anti-aging extravaganza

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Oliver Zolman, Bryan Johnson

Near-billionaire Bryan Johnson apparently does not like getting old and he’s trying to do something transformative about it. He and his team are experimenting in a big way.  As a 55-year-old myself, I can’t blame him for wanting to fight aging in general. However, his anti-aging project includes some extreme stuff. Will some in the

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2nd chances after big misconduct? He Jiankui, James Wilson, others

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James Wilson, Gene therapy

There have been rare instances like with scientist James Wilson where researchers were involved in what I would call major misconduct but somehow managed to bounce back. In a sense, they were given second chances in part by regulators but also by other scientists or supporters. However, after extraordinary misconduct, especially contributing to the death

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Reviews of P shot & O shot stabs at sexual enhancement

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Something called a P shot has sparked interest from some men interested in high-risk attempts at enhancement. The goal of today’s review post is to fact-check P shots. They’re sold for supposed penis enhancement or to address erectile dysfunction (ED). I’ll also fact-check so-called O shot stabs at vaginal rejuvenation or enhancement. These are both

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Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags

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ExoFlo from Direct Biologics

I wrote recently about how political pressure on FDA Commissioner Stephen Hahn in 2020 may have helped the Texas firm Direct Biologics move their product ExoFlo forward inside the agency. Today I analyze the ExoFlo Phase I clinical trial paper used in that push on Hahn to get the firm the IND for a Phase II

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FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics

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Former FDA Commissioner Stephen Hahn.

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

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