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The Niche
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Stem Cell & Regenerative Med Newsletter
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Weekly reads: death in CRISPR trial, sickle cell, nose picking & dementia, epilepsy
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As both a scientist who works on stem cells, cancer, and CRISPR, and a research advocate I've been fortunate to meet many patient advocates over the years. Some have been participants in clinical trials themselves. Benefits & risks of clinical trial participation It is very sobering to find out that a clinical trial participant has died. I remember when ALS …
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Review of ExoFlo paper used to push Direct Biologics IND inside FDA finds red flags
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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 trial. In my review as …
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FDA appeals Cell Surgical Network lawsuit verdict
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The FDA has finally filed an appeal of the Cell Surgical Network lawsuit verdict. It took them a very long time for some reason. The stem cell clinic chain Cell Surgical Network and other defendants had prevailed in a federal district court here in California in front of Judge Jesus Bernal. Their adipose cell product, stromal vascular fraction or SVF, might …
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