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Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem

June 26, 2024 / Professor Paul Knoepfler, Ph.D. / 4 Comments

FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I […]

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Weekly reads: CAR-T cell good news, Califf fight, stem cells on lymph

February 6, 2022 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Not everything in biomedical science is a ground-breaking discovery or clinical game-changer, but CAR-T cell technology is a combination of both. CAR-T cell good news We have such good news in this new pub on long-term benefits: Decade-long leukaemia remissions with persistence of CD4+ CAR T cells, Nature. Another recent CAR-T cell article, this one in Science,

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3rd Invitrx warning highlights FDA oversight weakness

January 4, 2023 / Professor Paul Knoepfler, Ph.D. / 8 Comments

The FDA seems oddly slow in oversight of unproven stem cell clinic-related firms like one here in California called Invitrx Therapeutics. I’ve written before about Invitrx, but interactions between them and the FDA have continued including a new warning letter. It’s become a puzzling situation. More broadly, the FDA has done relatively little in the past

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Did COVID derail FDA stem cell clinic plan?

June 30, 2022 / Professor Paul Knoepfler, Ph.D. / 2 Comments

The FDA stem cell clinic problem just continues to grow, while the agency has been oddly quiet in this space for more than a year. It’s been a major disappointment, particularly as in recent years FDA leadership had implied that bold action was coming. Their own words spiked expectations that the agency would tackle unproven

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Weekly reads: possible rare HIV cure, stem cell chicken, FDA commish

February 20, 2022 / Professor Paul Knoepfler, Ph.D. / 3 Comments

The idea of stem cells outright curing diseases is exciting and has powerful appeal, but media need to be careful about using the word cure in headlines and articles as we saw this week related to a possible HIV Cure. HIV cure via stem cells and chemo? The big news of the week was that

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Grading my 21 stem cell & regenerative medicine predictions for 2021

December 22, 2021 / Professor Paul Knoepfler, Ph.D. / 3 Comments

The world of stem cell research and regenerative medicine is unpredictable but it’s fun to be a part of it and try to do predictions. Each year in late December or early January I make prognostications for the coming year for stem cell research and regenerative medicine. I made 21 such predictions for the current

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21 Stem Cell Research & Regenerative Medicine 2021 Predictions

January 12, 2021 / Professor Paul Knoepfler, Ph.D. / 6 Comments

In any given field of biomedical science like stem cell research and regenerative medicine, it’s very useful if you can accurately predict the future. It seems, though, that predictions are far more difficult within the more exciting and rapidly-changing fields. The field of stem cells and regenerative medicine fits that bill. Past stem cell research

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