clinical trials

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

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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?

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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

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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

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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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Huge clinical trial fees allowed by FDA at times, details often secret

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Why can there be huge clinical trial fees for participants? I am often critical of for-profit stem cell clinics on this blog for numerous reasons. For instance, one thing that concerns me greatly about these clinics is that they charge patients to get experimental “treatments” that have not been proven to be safe or effective. But

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Poll: How do you feel about pay-to-play clinical trials?

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There’s a growing trend whereby patients have to pay to be in a clinical trial, which are called pay-to-play clinical trials. Proponents of this idea point toward potential benefits in the form of patients gaining access to innovative therapies. They also argue that this approach provides a much-needed funding mechanism for the trials and that

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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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Lessons from patients: stem cell clinical trials unlikely option for most patients

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How seriously do patients consider stem cell clinical trials? This is the first in a new series of posts I’m doing in lessons I’ve learned from the ever-increasing number of patients who contact me directly or are readers of this blog who make great comments. Today’s post is focused on the lack of availability of

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