Houston Research Organization Successfully Treats 24 Patients in FDA-Authorized Parkinson’s Study

[Farooqji]

In this Phase II, double blind, placebo-controlled study, 24 patients received six intravenous infusions of 200 million stem cells each over a 32-week period, or approximately 1.2 billion cells total. The trial is the first globally to administer pure mesenchymal stem cells, an adult stem cell harvested from fat, to Parkinson’s patients in such high quantities over repeat treatments.

hopebio.org/Article?N=000301

[JAS9]

Thanks for this. I've joined their registry and now I guess I wait to see what happens if anything. It's possible that I'll fit the criteria for the 60-patient stem cell study that uses stem cells donated by other people. There are a lot of disqualifying conditions. Still, it might be worth a try. It's strange that I'd never heard of this organization and clinical trial before now and it's been doing clinical studies for about 4 years. Once again, I've learned something that I probably wouldn't have without HealthUnlocked!

[MissRita in reply to JAS9]

what are the disqualifying conditions?

[Bolt_Upright]

The trial page says they are still recruiting. Probably not, but maybe? Includes contact info: beta.clinicaltrials.gov/stu...

[JAS9 in reply to Bolt_Upright]

This is from the original article published just 10 days ago:

"... the FDA-authorized trial for 60 patients using donor stem cells is still currently enrolling. This study, which uses stem cells from carefully selected donors, represents what HBRF hopes is a significant contribution in increasing regulatory acceptance of allogeneic adult cell therapies. Allogeneic therapies, with their dramatically reduced costs for manufacturing stem cells to a comparable safety profile, represent a potentially powerful way for ensuring equitable access to cell therapies in the future. Participants receive six intravenous infusions of 200 million stem cells each over the course of 32 weeks, or approximately 1.2 billion cells per patient. Participants can be male or female, must be between 45-80 years of age, and must have been diagnosed with mild-to-moderate Parkinson’s at least two years prior to commencement. There is no cost to participate."

So, yes they are still taking applications for that trial.

[gaga1958 in reply to JAS9]

It's only in TX? Did I get that correct?

[7springshollow in reply to gaga1958]

Yes. They hope to open more infusion stations in the near future but currently treatment is in Sugarland Texas.

[gaga1958 in reply to 7springshollow]

and do you know if the people in the study have to be on immune suppression? Thxs

[7springshollow in reply to gaga1958]

No they do not.

[gaga1958 in reply to 7springshollow]

that's good news but how does that work when the cells are from other people?

[7springshollow in reply to JAS9]

They have also started a trial for older patients with Parkinson's. I believe you must be 76 to participate. This trial for older patients is currently enrolling and had no cost to the patient.

[7springshollow in reply to JAS9]

Yes. This is one of the current trials. Both are set up the same except one will take any age and one is for 76 and older

[jeffreyn]

"We move next to data analysis and are eager to complete that process and publish results. Qualitatively, we have seen much we hope the data supports.”

I would imagine that it will be some months before the results are published.

[Boscoejean in reply to jeffreyn]

I would hope not but we can let you know how this all goes because my husband is in one of the clinical trials. Honestly I believe they are eager to get the information out there so that people can start to benefit from this treatment as soon as possible.

[JAS9 in reply to Boscoejean]

Please do let us know how it goes! Which trial was (or is) he participating in? If it's one of Hope's I have several questions. The first is: since they give half the participants the real medicine and half of them get only the placebo, do they ever give the medicine to the participants who got the placebo? Many trials do, just to be fair, but I don't see any mention of that.

Another question has to do with travel. I live 1900 miles from Houston, but I have friends near Houston. I could stay with them for maybe a few times, each time for a few days. Based on your experience, do you think this would work? Thanks for taking time to answer my questions.

[Boscoejean in reply to JAS9]

We live 2200 miles from Houston. My husband's sister and her husband live in the area so we can stay with them most of the time. I have communicated with someone who has met some of the participants in the earlier trials and she has seen benefits.

[7springshollow in reply to Boscoejean]

Only the first group of 24 that were required to pay to bank their stem cells will get the treatment after the study if they received the placebo. The free 60 person studies do not offer this option.

[Boscoejean in reply to 7springshollow]

thanks for the correction

[JAS9 in reply to Boscoejean]

Thank you so much! This information is very useful for me. Please, please, please let me know anything you discover as you discover it.

[DallasN]

did see this trial. But I have been skipping over it because the whole Hope Foundation looks like a scam. There are plenty of outfits that will take your money. But sadly almost none that are doing real cell treatment. And we know from the studies that have gone before that the delivery route is critical. The cells need to go into the brain. This is not going to happen with an IV.

[JAS9 in reply to DallasN]

Here's what they say:

"There is no cost to participate."

[jeffreyn in reply to DallasN]

"The cells need to go into the brain. This is not going to happen with an IV."

Regarding the mode of action of mesenchymal stem cells for PD, I think the jury is still out. It is interesting that the Michael J. Fox Foundation is listed as a collaborator for a very similar trial at the University of Texas.

Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPD:

clinicaltrials.gov/ct2/show...

[7springshollow in reply to jeffreyn]

During an IV infusion it is estimated that 20% of the cells end up in the brain. Hope bioscience is using very high numbers of stem cells and multiple infusions to assure an adequate number of stem cells end up in the brain to be therapeutic .

[jeffreyn in reply to 7springshollow]

Thanks very much for all of your inputs to the discussion on this thread.

After reading all of your replies, I get the clear impression that you are an insider. Are you able to share with us your situation (e.g. a connection to Hope Biosciences)?

Also, are you able to supply a reference for the 20% figure you quoted?

Thanks.

[7springshollow in reply to DallasN]

All trials at Hope are free. They are also FDA approved. The phase 2 trials required you to bank your stem cells but there was no cost for the trial and the currently enrolling trials are free with no banking requirements.

[MissRita]

well that is very impressive

[7springshollow]

This particular trial is completed and we are awaiting the results. Several others through the same organization are still enrolling. Check out YouTube videos from Hope bioscience to see how they are different.