Bayer/Blue Rock About to Start Phase 3 Trial

[jimcaster]

Since my diagnosis nearly 7 years ago, I have been most optimistic about the possibility of stem cell therapy for Parkinson's disease. This is the most promising development I am aware of. bluerocktx.com/bluerock-the...

[RonB1]

Thanks for sharing. I am interested in the BlueRock procedure as well.

[scotta]

I've been following this as well. I'm not sure how I feel about using sham surgeries in the control group. They are doing surgery on your head for everyone in the study so that the patient doesn't know whether they got the treatment or the placebo. I suppose it's just scalp surgery rather than full-blown brain surgery, but it's still a bit daunting.

[jimcaster in reply to scotta]

I completely agree. It seems that after decades of double blind studies, we should be able to determine a typical "placebo effect" in Parkinson's Disease trials and measure the active participants versus the typical / median / average placebo effect. Especially with regard to trials like this, it seems almost unethical. It's one thing to ask someone to take a sugar pill. It's quite another to have them undergo sham brain surgery.

[scotta in reply to jimcaster]

As I recall, the Phase I BlueRock study used a protocol where all the patients received either a low dose or a high dose of the treatment and the safety and efficacy were assessed without using a placebo. I wonder what made them change to a study that used the sham surgery.

[Patient100 in reply to scotta]

My understanding is that the sham surgery is needed because a stringent placebo-controlled trial is the standard for FDA regulatory approval which BlueRock is seeking for this new Phase 3 study. Especially when the endpoint has an element of subjectivity. This is different to a Phase 1 or 2 study (without a placebo arm) where one is just looking to see if the concept will likely work.

[CuriousMe12]

It's good that it's gone to phase 3. I just wish that trials could be speeded up. 1.5 years trial. Add on a start of 6 month from now and 6 month analysis. Could be a few years to go if successful.

[Obiora in reply to CuriousMe12]

Its still way faster than we could have expected by going directly to a phase III study

[Farooqji]

Have you applied for enrollment