Search Results for: clinicaltrials.gov

Regenerative reads: brain organoids, Clinicaltrials.gov change

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brain organoids sm

Sometimes change takes a very long time, but with brain organoids or advocating for better information for patients at Clinicaltrials.gov, after waiting you can see some interesting developments.  These are two of the regenerative medicine stories of the week, along with some striking research papers. Clinicaltrials.gov Some of us have been advocating for improvements at […]

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FDA outlines potential crackdown on Clinicaltrials.gov offenders

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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 Based on new draft guidance

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Clinicaltrials.gov Mission At Risk From Proliferating For-Profit Trials

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slickstem

It’s hard to even imagine the world of investigative medicine without the wonderful resource of Clinicaltrials.gov, the global hub for clinical trial listings. I recently interviewed the Director of Clinicaltrials.gov, Dr. Deborah Zarin here, which is a fascinating read. As great as Clinicaltrials.gov is as a resource, unfortunately it faces a new, rapidly growing problem that is a serious

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Interview with Clinicaltrials.gov Director Deborah Zarin

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clinicaltrials.gov_

This post is the first in a series about the Clinicaltrials.gov website. This piece is an interview the Director, Dr. Deborah Zarin. I want to thank her for taking the time to answer my questions. Later, I will post Part 2 in which I discuss my concerns about the trend of for-profit stem cell clinic trials

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RFK Jr. & claimed regenerative peptides like BPC-157

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Bpc-157, Body Protection Compound 157

The marketing of what are loosely referred to as “regenerative peptides” including BPC-157 makes many health claims. Yet I can’t see that any have been conclusively proven to work in people. Even so, RFK Jr. claimed that the FDA was suppressing useful peptides. He mentioned this along with supposed suppression of “stem cells”. So maybe

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FDA letters to Chara Biologics & Evolutionary Biologics continue its unprecedented slew of warnings

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Dr. Joy Kong, Chara Biologics, Chara Health

What is Chara Biologics? Why did the FDA just warn them and another firm? FDA’s CBER keeps up fast pace of warnings Before we get into that, the FDA biologics branch, CBER, has more generally kept up an unprecedented pace of warning letters over the past 13 months. I wrote late last year how 2024

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NAE member Mary Pat Moyer on FDA Warning Letter to her firm INCELL Corporation

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A Texas firm called INCELL Corporation has received an FDA warning letter about an amniotic product it manufactures. The letter was addressed to the firm’s founder and leader Dr. Mary Pat Moyer. The letter is somewhat unusual as Dr. Moyer is the Chief Science Officer of INCELL, and is an academic scientist with over 250

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2025 PRP fact-check and review: cost and possible benefits

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PRP-Platelet-Rich-Plasma-being-injected-into-a-hand

Platelet-rich plasma or PRP has become one of the most commonly used regenerative products at unproven clinics. The orthopedics departments at many universities are now offering PRP as well. What is behind this trend? How much data are there to back up all this enthusiasm for platelet-rich plasma? The goal of this post is to

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QC Kinetix review: concerns on huge regenerative clinic chain

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Tyler Vail, QC Kinetix

QC Kinetix is a relatively new regenerative clinic brand in the U.S. selling unproven cell therapies. I see several specific red flags including a proposed class action lawsuit. The company reports having 150+ locations, making it potentially the largest chain of unproven clinics in the U.S. Collectively, these clinics could be seeing tens of thousands

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