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

March 26, 2020 / Professor Paul Knoepfler, Ph.D. / 4 Comments

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

March 22, 2020 / Professor Paul Knoepfler, Ph.D. / 7 Comments

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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Liveyon is back (again) with unproven exosome product

March 12, 2020 / Professor Paul Knoepfler, Ph.D. / 11 Comments

Remember our old friends Liveyon? Their leader John Kosolcharoen? Liveyon’s continuing metamorphosis This biologics supply firm has gone through several stages of corporate metamorphosis as a supplier of biologics including at first a purported living umbilical cord stem cell product. That stem cell thrust ultimately landed a dozen or more people in the hospital as

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The Niche COVID-19 updates & resources

March 10, 2020 / Professor Paul Knoepfler, Ph.D.

stem-cells-for-COVID-19-infographic_small

The novel coronavirus and the disease it causes, COVID-19, have swept the world with few proven treatment options. Vaccines are only recently being rolled out the last 2 or so months, which gives some real hope. While the novel coronavirus-caused illness is generally a mild disease in kids (many of whom don’t even show symptoms),

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Regenerative medicine recommended reads including $191 million to researcher

March 8, 2020 / Professor Paul Knoepfler, Ph.D. / 4 Comments

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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Heads up on Hui Yang, another potential aspiring CRISPR baby researcher

January 22, 2020 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Making a CRISPR baby is a controversial idea to even propose now for many reasons, yet even after He Jiankui’s train wreck some people have seemed eager to try it including apparently a scientist whose name perhaps many readers here are not so familiar with in this context: Professor Hui Yang. ‘CRISPR baby guys’ Is

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Why did clinic supplier Liveyon halt sales but others kept going despite FDA?

December 16, 2019 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Umbilical “stem cell” supplier Liveyon has suspended sales of its products according to the WaPo after a harsh FDA warning letter. While not fully shutting off the tap to the perinatal stem cell clinic universe, as other suppliers including in Utah seem to be continuing, this Liveyon voluntary hold will equal a major reduction in

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‘I’d need a drink’: WaPo deep dive on clinic firm Lung Health Institute

December 7, 2019 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Washington Post reporters William Wan and Laurie McGinley have a new piece on the unproven regenerative clinic firm the Lung Health Institute. This article has a number of surprises and new insights. Previously the Lung Health Institute was called just the Lung Institute. It was recently acquired by the publicly-traded company H-CYTE, stock symbol HCYT. In the

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Whatever happened to the STAP cell scientists including Haruko Obokata?

November 14, 2019 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Once upon a time this blog and major outlets around the world were regularly writing about a Japanese stem cell researcher named Haruko Obokata (小保方晴子). Whatever happened to Obokata and the other folks directly involved in STAP cell research? First, a bit of background because maybe still a few people never heard of STAP cells

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Unnatural Selection review: captivating mind-bender but needed more science

October 28, 2019 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Unnatural-Selection-with-patient-Jackson-Kennedy

Today’s post is a review of Unnatural Selection, the new Netflix science docuseries focused on CRISPR and other disruptive genetic and reproductive technologies. The show is an interesting mix of personalities and stories from patients, scientists, biohackers, and more. One patient thread is the story of a wonderful little boy named Jackson Kennedy. He wants

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