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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: bat stem cells & viruses, Lineage Cell, He Jiankui visa

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bat stem cells, stem cells

Occasionally when I write a post there is an angry reaction to it in the blog comments, which was the case for my recent fact-check of the LifeWave X39 patches.  As you can see in that post, I didn’t find convincing data to either back up the claimed stem cell connection. In my opinion, there

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Does NurOwn from BrainStorm Cell Therapeutics still provide hope for ALS?

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Chaim Lebovits, CEO of BrainStorm Cell Therapeutics.

What is the cell therapy for ALS called NurOwn? How strong is its potential as a treatment for ALS? I’ve been following the biotech BrainStorm Cell Therapeutics for many years. Patients keep asking me about NurOwn ALS prospects. They’re looking for hope. Today’s post is a close look at NurOwn and at BrainStorm as a

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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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Weekly reads: CRISPR, FDA stem cell loss, pioneering AMD study, MS, Verve Therapeutics

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FDA stem cell policy flow chart.

The big news of the week was the big FDA stem cell in court by Judge Jesus Bernal here in California, who ruled in favor of a chain of stem cell clinics called Cell Surgical Network. The FDA had been seeking an injunction against the clinics. I believe the ruling was founded in part on

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Fact-checking exosome therapy: costs, risks, & lack of data

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model of an exosome, exosome therapy

Exosome therapy is a still-experimental cell therapy approach aimed at treating specific diseases using secretions from cells. It’s novel since most attention on cell therapies has been given to using the actual cells themselves. In addition, this approach is a newer idea than using cells as the drug to treat diseases. Interestingly, the term “cell

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Regenerative medicine reads: retraction, FDA warning, CAR-T, ARM CEO

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Timothy D. Hunt, new CEO of ARM, Alliance for Regenerative Medicine

I’ve tried to find some time to do some stem cell and other regenerative medicine reading too, but it’s been a busy week of teaching for me as a professor in our new academic year for the UC Davis School of Medicine. I help to teach the Histology part of the first-year curriculum. It’s an

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