Search Results for: u.s. stem cell

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

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Robert Califf, FDA Commissioner

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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Concerns after interview with Kyle Cetrulo of Perinatal Stem Cell Society

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Perinatal Stem Cell Society email material.

I recently interviewed Kyle Cetrulo of the Perinatal Stem Cell Society. This organization seeks to catalyze big changes in stem cell use and clinical trials in the U.S. In the interview, we touched on many topics including FDA oversight of the cell therapy space. Some of this discussion was in reaction to the new Utah

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US clinics selling unproven RGCC cell therapies in addition to SOT

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FL RGCC cell therapy

I wrote a few weeks ago about a firm called RGCC or Research Genetic Cancer Center, which sells what I see as an unproven RNA therapy to clinics throughout the US. The approach is called supportive oligonucleotide therapy or SOT. After buying it from RGCC, the clinics then sell SOT injections for Lyme disease, other

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Perspectives 10 years after STAP cells: the culture of science, misconduct, & hopes for progress

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Haruko-Obokata-小保方-晴子-

Exactly ten years ago today, on January 29, 2014, I wrote about two new Nature papers on so-called STAP cells. The papers claimed that stress alone could convert regular non-stem cells into some of the most powerful stem cells. More specifically, the authors claimed to make pluripotent stem cells similar to iPS cells this way.

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Textbook case of bad media on ‘stem cell treatment’ clinic: Kirk Cousins Caribbean trip

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Kirk Cousins, stem cell treatment

It’s frustrating to see so much bad media coverage of celebrity trips to clinics to get supposed stem cell treatment of various kinds. Part of the concern here stems from ordinary people taking risks by following the example of the famous people.  Good journalism should ask tough questions, talk to experts, and not yield an

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2023 stem cell predictions grades reflect wild year for regenerative medicine

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stem cell predictions

Every year I make stem cell and regenerative medicine predictions. Looking at my predictions for 2023, they reflect a wild year but in many ways a good one overall. Below I have graded my 2023 predictions. Overall, my crystal ball gave solid results. Some of the predictions have been condensed to keep things concise, but you

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Surprising new FDA remarks to AABB on cord biologics misuse & stem cell clinics

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AABB, FDA

The Association for the Advancement of Blood & Biotherapies or AABB recently had a very useful Q&A with the FDA on cord blood use. There are some important new things from the FDA on the marketing and use of cord blood in there. The agency was also quite blunt in some ways about the challenges,

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Weekly reads: FDA OKs 2 gene therapies for sickle cell, new Paolo Macchiarini series, Fujifilm

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Marie Tornyenu, Casgevy gene therapies for sickle cell

The big news broke Friday that the FDA approved two new gene therapies for sickle cell disease. While the approvals were expected and the actual use of these treatments will be complex on several levels, this is a historic development. 2 FDA-approved gene therapies for sickle cell Friday’s news follows on recent UK approval for

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Weekly reads: late Macchiarini retractions, stem cells & Lululemon

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Paolo-Macchiarini

Paolo Macchiarini is one of a small group of people in the stem cell universe whose misconduct has blown up in the press. Piero Anversa, Haruko Obokata, Hwang Woo-Suk, and some operators in the unproven stem cell clinic sphere come to mind. Macchiarini published quite a few seriously problematic papers, some of which just hung

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Man reportedly dies after getting unproven stem cell therapy in Mexico

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stem cell death, stem cell therapy in mexico

A surfer news site reported that a man recently died after getting an unproven stem cell therapy in Mexico. The article is entitled Tragedy strikes in Mexico as Shane Dorian’s traveling companion for “life-altering” stem-cell therapy dies. Shane Dorian is a famous surfer who hopes to fight aging at 51. As part of that effort, Dorian

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