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Overplaying N=1 in the stem cell therapy world

stem cell therapy

The regular emails and phone calls I get from patients asking questions about stem cell therapy are a powerful reminder of the fact that research in our field can be very personal. Sometimes individuals who receive experimental stem cell therapy (or other cell therapies) and seem to have a positive outcome can end up becoming […]

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End of FDA “grace period” impacted perinatal cell therapy biotechs

knot in umbilical cord, perinatal cell therapy

If there’s one area of biologics where the FDA has been consistently busy lately it’s the perinatal cell therapy space. The agency has made it clear in the last year that allogeneic birth-related cell products are often drugs requiring premarket approval. This has mainly manifested at a practical enforcement level. We’ve seen actions taken in

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Weekly reads: Google, stem cells & MS, VSELs, ‘hairy’ organoids, MYC

stem cells differentiating into neurons and glia

It’s been quite a ride doing this blog on stem cells and other technologies for more than a dozen years. So far it seems like I’ll keep it going. A large part of the reason is because of people needing good information about our field. Those people include scientists and physicians but also many in

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Centers for Respiratory Health is new incarnation of clinic Lung Health Institute

Centers for Respiratory Health, lung health institute

Many firms that generally fall into the category of unproven stem cell or cell therapy clinics have a way of reinventing themselves and I’ve seen this with one formerly named the Lung Institute that is now called Centers for Respiratory Health. First the Lung Institute became the Lung Health Institute. Now that firm has become

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Weekly reads: Yale scientist suspended, WA AG sues clinic, new pubs

Dr. Tami Meraglia has been sued by the Washington State AG for selling unproven stem cells.

It’s very challenging to be an academic scientist even under normal circumstances so when a government starts going after researchers for things like supposed irregularities in funding disclosures, it can cause serious problems if not carefully overseen. We’ll start this week’s recommended reads with the feds monitoring such disclosures and even making referrals to the

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Biotech California Cultured aims to sell lab-grown chocolate

California Cultured lab-grown chocolate. Pic by Paul Knoepfler.

I’m fascinated by the idea of making food from cells grown in a lab and especially the newest idea of lab-grown chocolate. While lab-grown meat has gotten the most attention, (see my recent post on test-tube meat: Not Old MacDonald’s Farm: is the future lab-grown meat?) I’d say that the coolest application of making food from

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Feds want $3M, prison for Liveyon founder in old fraud case

John-Kosolcharoen-Liveyon-Bad-Batch

Before starting the umbilical cord cell supplier and marketing firm Liveyon, John Kosolcharoen was involved in some alleged health care fraud. The feds brought a case against him related to prescription drugs. Older case coming to a head As Liveyon was having its misadventures in the stem cell clinic sphere, the status of that past

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Elizabeth Holmes, Theranos, & lessons for the stem cell field

Elizabeth Holmes, Theranos

When I read about Elizabeth Holmes and her blood testing startup Theranos I see parallels to hucksters in the arena of stem cells and cell therapy. I’m thinking especially of the unproven stem cell clinics out there. It goes farther than that though too, including people who aren’t hucksters at all but get caught up

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