clinical trials

Hoping for approval, Mesoblast says FDA wants new remestemcel-L trial

August 3, 2023 / By / 1 Comment
mesoblast ceo dr silvio itescu

Australian biotech Mesoblast has had a rollercoaster ride working toward FDA approval of its mesenchymal cell therapy product remestemcel-L. They are seeking approval for use in patients with graft-versus-host disease (GvHD). More specifically, it is intended for pediatric patients with steroid-refractory acute graft versus host disease, or SR-aGVHD. This is a serious condition and new treatment …

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Mayo Clinic charges patients just to talk about clinical trials?

February 14, 2022 / By / 7 Comments
The Mayo Clinic.

What if some legit place like The Mayo Clinic charged people just for the opportunity to talk to a doctor about possibly enrolling in a clinical trial? Imagine this kind of conversation. “Hey, Doc, I have this medical problem and heard you have a relevant clinical trial. Tell me about it.” Then the doctor fills …

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COVID-19 stem cell trials pile up during novel coronavirus outbreak

February 1, 2021 / By / 15 Comments
2019-nCoV-CDC-23313-COVID-19

Could stem cells help patients with the novel coronavirus disease COVID-19? It’s hard to say at this point. Is it worth doing trials during the outbreak to find out? Three new clinical studies have popped up on Clinicaltrials.gov investigating the potential of stem cells to help patients infected with the new coronavirus 2019-nCoV. Update, the …

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Hope on Parkinson’s front: Japan IPSC trial 1st patient

February 1, 2021 / By / 2 Comments
Fig-3i-Kikuchi-et-al.-Nature-2017-IPS-cell-Parkinsons-

In Parkinson’s Disease patients develop neurological dysfunction as they lose a special kind of brain cell called dopaminergic (or dopamine) neurons. While a number of different approaches to this disease have been studied for decades, nothing has proven particularly successful in slowing its progression. As a result there has been a big need for novel thinking …

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Possible safety concerns from new stem cell, RPE vision loss study report

February 1, 2021 / By / 2 Comments
Figure-1-Mehat-et-al.-AAO-Journal-2018-810x1024-1

With stem cells for vision loss, first we want to be sure a treatment won’t make things worse. Several teams around the globe are rigorously studying stem cell-based approaches to vision loss via regulatory-compliant studies including for macular degeneration with some results cautiously upbeat on safety from early phase analyses, but data from a new study on …

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Cord blood for cerebral palsy: mostly discouraging new trial data

February 1, 2021 / By / 6 Comments
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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Stem cell therapy review of good news: UC Davis, Asterias, Cynata, Mesoblast, ViaCyte

February 1, 2021 / By / 2 Comments
VC-01-post-implant-final1-e1503703572933, viacyte

It’s a difficult, but very important road to conclusively prove that an investigational stem cell therapy is both safe and effective in order to get final approval FDA or equivalents in other countries. For this reason, it is beneficial to highlight even small, but positive steps forward including encouraging pre-clinical data. Today I’m doing a …

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Interview with Clinicaltrials.gov Director Deborah Zarin

March 6, 2021 / By / 4 Comments
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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Maps of global stem cell clinical trial trends

February 1, 2021 / By / 9 Comments

Late in 2012 I did a piece on the global trends in stem cell clinical trial patterns. It is time for an update. Another look at stem cell clinical trials now (late Sept. 2013) based on the clinicaltrials.gov database shows an encouraging trend. Total Stem Cell Clinical Trials The total number of stem cell clinical …

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Major Japanese newspaper reports iPS cells already transplanted into human patients at Harvard

February 1, 2021 / By / 5 Comments
iPS-cell-headline-clip1

It seems like just yesterday I was blogging about how concerned I was that iPS cells might be used in early phase human clinical trials as early as next year and that would be high risk given safety concerns about iPS cells. Oh, it was yesterday. Now today….. Yomiuri Shimbun, one of the top newspapers …

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