Search Results for: als

FDA outlines potential crackdown on Clinicaltrials.gov offenders

Anderson-et-al-Clinicaltrials.gov_

Clinicaltrials.gov is a wonderful resource for its many users, whether a patient searching for a clinical trial to actually participate in or someone doing research as I have done, but it’s not perfect and some sponsors have been breaking the rules regarding its use. It’s a major problem in fact. Based on new draft guidance …

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60 Minutes Australia Pushes Unproven Stem Cells for Cerebral Palsy

stem-cells-cerebral-palsy-60-minutes-ad

The 60 Minutes show here in the U.S. has done sobering segments over the years on risky, unproven stem cell clinics, but now there is a new episode of 60 Minutes Australia that is the polar opposite: it mostly made a mess of things with its fluffy coverage of the story of a wonderful little …

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New lawsuit against U.S. Stem Cell also alleges blindness

stem-cells-eyes, stem cell therapy side effects.

A new stem cell clinic lawsuit has popped up and this one, like some others, relates to a patient alleging vision loss due to a non-FDA approved stem cell offering and involves U.S. Stem Cell, Inc. (formerly called Bioheart). American stem cell clinics market direct-to-consumer stem cell offerings for a whole medical dictionary’s worth of …

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Cord blood for cerebral palsy: mostly discouraging new trial data

umbilical-cord-blood, umbilical cord blood stem cells

Some notable newly published Phase II data from the Duke cord blood for cerebral palsy trial unfortunately doesn’t give much reason for optimism that this approach is going to have a substantial positive effect for these kids. The double-blinded, placebo-controlled study did not find a meaningful benefit overall from infusions of autologous cord blood (ACB) for …

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ViaCyte Interview on Diabetes Stem Cell Trials & Cool Role of Gore-Tex Tech

ViaCyte

When I think of the promise of stem cells for diabetes, the privately held California stem cell firm ViaCyte is the first biotech that comes to mind now. It has promising stem cell clinical trial work building. Today’s post is a new interview with the company’s CEO Paul Laikind. For past posts on ViaCyte see here, which …

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Honoring stem cell advocate Ted Harada, $2,000 donation to Emory ALS Center

Harada-Pic-donation

The late Ted Harada, who was my 2016 Stem Cell Person of the Year, was a powerful patient advocate for stem cells and for ALS patients. Each year I give out a Stem Cell Person of the Year Award including a $2,000 prize that I provide myself to the winner, and Ted won that last …

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How risky are stem cell trials for Parkinson’s beginning in China?

Brain-PET-scan

New human clinical trials using derivatives of pluripotent stem cells in China for Parkinson’s Disease (PD) have raised expectations and some eyebrows. PD is a neurodegenerative condition, sometimes diagnosed or followed by PET scans such as the one at left, characterized by loss of dopaminergic neurons leading to severe and sometimes life-threatening symptoms. Pluripotent stem …

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FDA warns Northwestern’s Richard Burt on reporting patient deaths, other issues in stem cell trials

Richard-Burt-Warning-Letter-e1490745772151

The FDA recently issued a lengthy warning letter to Northwestern University over the clinical trial practices of its Dr. Richard Burt and this letter just popped up on the FDA website. To my knowledge this is an unprecedented event as I’m not aware of another warning letter to a major university for a stem cell trial. Burt received the FDA …

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Fractals, fibonacci, & food: romanesco wows in garden

Romanesco-Knoepfler

As some of you readers know, in addition to being a scientist, I’m also an avid gardener and photographer. Every now and then I do posts on gardening or photography. I feel like I bring a scientist’s eye to the garden and that was true a few days ago when I captured the above picture of …

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Good stem cell news on trials, FDA, cool new papers & more

Pericyte-paper

In the whirlwind that is the stem cell and regenerative medicine world, there are many concerning things that need attention, but also good stuff happens too and this post focuses on the positive. The Asterias spinal cord injury clinical trial, a phase 1/2a trial called SCiStar, continues to make encouraging news with a clean safety profile …

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