Heidi Ledford.

CRISPR often damages human embryo chromosomes

human-embryo-modification

Three new studies reported in preprints all show severe DNA damage to human embryos from CRISPR a surprisingly high percentage of the time including in some cases loss of heterozygosity (LOH). Anywhere from about a quarter to half of CRISPR’d embryos exhibited major genome damage. As readers of The Niche know, I never was a …

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Regenerative medicine recommended reads including $191 million to researcher

Mark-Pennesi-CRISPR-regenerative-medicine-eye

It’s notable how the FDA now considers gene-editing a kind of regenerative medicine. This means that various gene therapy products in development technically qualify as regenerative therapies. Ever since the agency began its rapidly growing regenerative medicine advanced therapy (RMAT) designation program, we’ve seen an increasing number of gene therapy biotechs and products qualify as …

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Negative stem cell clinic outcomes include 3 blinded women

Michael-Miller-MD-PhD-e1473364751156

What can go wrong with unapproved stem cell clinic offerings? The answer including from presentations at the FDA today turns out to be very serious, negative results right here in the U.S. Thomas Albini, MD gave a talk entitled,  “Severe Visual Loss After Intravitreal Injection of Autologous Adipose Tissue-derived Stem Cells for Age-related Macular Degeneration”. …

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