Search Results for: us stem cell

Stem cell clinic Nervana new ad claims no side effects & FDA OK

Nervana-ad-march-28

Stem cell clinics like Nervana are spreading like wild-fire across the U.S. A few months back the Sacramento area got a new stem cell clinic selling amniotic stem cell therapies for a variety of ills including most prominently arthritis and pain. This clinic is called Nervana Stem Cell Center. I first noticed it via a

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REGROW Act is Attack on Science-Based Stem Cell Trial Oversight

REGROW-Act

Senators Mark Kirk, Joe Manchin, and Susan Collins have proposed new legislation in the form of the REGROW Act that would substantially interfere with the FDA’s ability to properly regulate the development of new stem cell and regenerative medicine therapies based on hard science. The REGROW Act would force the FDA to allow rushed introduction of experimental stem

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Sacramento amniotic stem cell clinic advertises again, but by another name

Lee-Medical-Group-Stem-Cells

Remember Nervana Stem Cell Center, an amniotic stem cell clinic here in the Sacramento area, which I’ve posted about before here and here. One big question about Nervana remains unanswered: is its apparent marketing of amniotic stem cells for arthritis and other conditions is OK with the FDA? Another question has been, “who are the medical

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You can’t retract a designer baby: CRISPR, social justice, & risks

CRISPR-baby-retraction

There’s a questionable notion floating around out there in the numerous discussions over heritable human genetic modification and CRISPR. This idea goes that if germline human gene editing goes awry for any number of reasons, scientists could simply reverse it by applying genetics again. The reversal notion does not fit with the reality of science

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Cons Outweigh Potential Pros to BPC Plan on Stem Cells & FDA

BPC-report-stem-cels

There is considerable interest in FDA regulatory reform here in the U.S. for stem cell therapies. The goal is to get new treatments to patients faster, but is there a way to do that without sacrificing proven safety and efficacy? You need convincing data on both safety and efficacy or speed becomes dangerous. Bipartisan Policy Center

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New Stem Cell Clinic Trial for Alzheimer’s: Perspectives & Questions

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A team at the University of Miami has launched a claimed first of its kind stem cell clinic trial for Alzheimer’s Disease (AD). The trial seems somewhat unique in using mesenchymal stem cells (MSC) for AD and is being run with biotech Longeveron. You can read more on the actual clinic trial including all the

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Content Wiped on Websites of Stem Cell Clinics Warned by FDA

Irvine-Stem-Cell-Treatment-Center

A couple of months back, the FDA issued a warning letter to three co-owned stem cell clinics selling fat stem cell-based interventions to patients for a variety of ills. You can read all about the warning letter here. It went to lead clinic, Irvine Stem Cell Treatment Center as well as the two co-owned clinics, which

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Important, endangered species in stem cell medicine: the phase III trial

stem-cell-clinical-trial-system

Traditional clinical trials have four phases. Each phase plays an important, unique role in testing whether new drug products are safe and effective as well as how they compare to the standard of care. Today in the stem cell field across the globe, the Phase III is under fire including what some might call friendly

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