Good news for human embryonic stem cell therapeutics- BlueRock received "fast track" designation for dopamine neurones

[Farooqji]

Good news for human embryonic stem cell therapeutics- BlueRock received "fast track" designation for dopamine neurons derived from human embryonic stem cells for treatment of Parkinson's disease.

prnewswire.com/news-release...

[Hidden]

I would like to hear the opinions of those familiar with the workings of the FDA about this fast tracking. How will this precedent effect other stem cell trials?

[Canddy in reply to Hidden]

Though this study is fast-tracked it does not mean that other stem cell trials will not be fast-tracked while the BlueRock trial is being conducted - they should be considered individually. However, if results are positive for the primary objective of the BlueRock Phase 1 trial (safety and tolerability of stem cells one year post transplant - estimated completion in Jan 2023) then it could be easier for other stem cell trials/therapies to gain fast-track status.

[Canddy in reply to Canddy]

It also looks like company leadership at BlueRock believes in their stem cell therapetic:

fiercebiotech.com/biotech/b...

And I know the statement below is coming from a new CEO of a pharma company but I find hope in his statement regarding the direction of the company:

"We have begun our journey to change medicine and to address some of the most devastating degenerative diseases, where currently we can only offer a slowed trajectory of deterioration. Our mission is to create a living medicine that can address the complex nature of these diseases, and in turn, create hope not just for treatment of symptoms, but for a cure. I cannot imagine a more exciting time to lead BlueRock,"

I hope they succeed.

[Despe]

". . .human embryonic stem cells. . ."

No, thanks, I will pass!!!

[Hidden in reply to Despe]

I’m hoping for the stem cells derived from our own skin, personalized cell therapy. Far more advanced and coming to trial at Mass General hopefully this fall/winter.

[Despe in reply to Hidden]

CC,

That is the most desired stem cell therapy--using your own skin without fear of rejection.

[kevowpd in reply to Despe]

Easier to be dismissive when you don't have PD.

[Despe in reply to kevowpd]

Not me, my husband says so, and I support him.