More Stem Cell Clinical Trial news from Simon Stott, The Science of Parkinson’s:
Oooh! @BlueRockTx goes Phase 3!
The company plans to initiate a Phase 3 clinical trial for bemdaneprocel (its investigational cell therapy) for #Parkinsons; With RMAT designation, the "exPDite-2" study is expected to begin in the first half of 2025
bluerocktx.com/bluerock-thera…
Great news. Thanks for sharing
They are starting phase 3 straight after phase 1. Are they skipping phase 2?
From their press release yesterday - "The advancement to this registrational trial follows discussions with the U.S. Food and Drug Administration (FDA) under the Regenerative Medicine Advanced Therapy (RMAT) designation granted by the FDA in May 2024. "
So, in essence the FDA is aware that they are "skipping" Phase II. They may have some extra parameters in the Phase III study to address what usually is addressed in Phase II
It's very positive approach. They have designated it s fast track trial with FDA. As per FDA website, this designation is defined as follows:
"The Fast Track designation is a process from the United States Food and Drug Administration (FDA) that speeds up the development and review of drugs for serious conditions. The goal is to get new drugs to patients faster.
What does the Fast Track designation do?
Helps researchers develop new treatments
Reviews safety and effectiveness data
Ensures problems are caught early and resolved
Results in more frequent communication between the FDA and the manufacturer
**What conditions qualify for the Fast Track designation?
Serious or life-threatening conditions
Conditions that impact survival, day-to-day functioning, or the likelihood of progression
Conditions that address an unmet medical need"
Hope that this trial will be completed in our lifetime with success!!
Excellent news, thanks for sharing
I can open the link. Is this for the director brain version or the infusion?
Thanks for sharing this article.
Clinical Trial Update 
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