Active recruitment for stem cell trial

[Farooqji]

Hope biosciences is actively recruiting for PD04, a Randomized, Double-Blind, Single Center, Phase 2, Efficacy and Safety study of allogeneic HB-adMSCs vs Placebo, for the Treatment of Patients with Parkinson's disease.If you or someone you love suffers from #ParkinsonsDisease please follow the link to learn more about study details

hopebio.org/study?Name=HBPD04

[jeffreyn]

I don't understand why they are having so much difficulty recruiting PwPs for this study. After almost 2 years of recruiting, they have only managed to enroll 30 of the 60 participants sought.

[Farooqji in reply to jeffreyn]

I think the main reason is that patients have to bear the cost themselves

[jeffreyn in reply to Farooqji]

From the section titled Frequently Asked Questions:

"All costs directly related to an FDA-authorized study, including treatment, lab tests, imaging, exams, evaluations, and supplies, are covered and offered at no cost to trial participants."

[billybobAK in reply to jeffreyn]

My travel. Cost have been almost $6,000 to$7,000 for the. 7 required visits to. Houston and I may have gotten the placebo.

[jeffreyn in reply to billybobAK]

Wow! Did they tell you at the beginning that they would not be covering your travel costs?

[billybobAK in reply to jeffreyn]

I knew it was a gamble from the getgo.

[jeffreyn in reply to billybobAK]

"I may have gotten the placebo"

Does this mean that you have not noticed any benefit after the 6 IV infusions?

[billybobAK in reply to jeffreyn]

Correct

[billybobAK in reply to billybobAK]

I would probably do it again every thought I thinking I got the placebo. Hope bioscience has good and professional staff.

[jeffreyn in reply to billybobAK]

On the Clinical Trials website, the study record for this trial says that they are still recruiting. The Estimated Study Completion Date for the trial is given as January 2024. Even if they recruited someone today, they would need about 56 weeks to screen (up to 4 weeks), treat (32 weeks) and follow-up (20 weeks). So a realistic Estimated Study Completion Date is more like December 2024 (at the very least).

clinicaltrials.gov/study/NC...

The Hope Biosciences webpage for this trial still says that they have only managed to enroll 30 of the 60 participants sought. Do you have any insight as to when they might pull the plug on recruitment and wrap this one up?

hopebio.org/protocol?name=H...

[Boscoejean]

the research is in Texas - considering that there are probably a lot of Parkinson's patients living in Texas alone I have to think that either the information is not getting out or the neurologists are not encouraging patients to participate. I speak from experience. When I mentioned this research to the neurologist my husband was seeing he did not believe it was possible. (He was not in Texas)

[HugoRipanykhazov]

the most promising research in this area concerns injecting cells directly into the brain. It is known as "The Swedish Study"

I cant imagine it is particularly easy to get people to participate in a study involving massively invasive brain surgery.

I am 5 years in, symptoms still mild, and just discovered that in 1996, my wife harvested placenta cells from our first offspring and has been paying to store them ever since!

I'd be very interested indeed in the results of any study where the results are as marked as this Swedish Study but even I would think twice before going for such brain surgery.

[jeffreyn in reply to HugoRipanykhazov]

This stem cell trial by Hope biosciences does not involve brain surgery.

[gomelgo in reply to jeffreyn]

Injecting something into the brain, brain surgery ... seem the same to me in terms of what I personally would be willing to consider.

[jeffreyn in reply to gomelgo]

Hope Biosciences are injecting something into the vein, not into the brain.

classic.clinicaltrials.gov/...