What happened to the stem cell trials

[Farooqji]

There were 3 or 4 major trials going on for the last 3 to 4 years namely

1. International stem cell corporation hpNSc trial

2. Kyoto university trial

3. Chinese trial

And some more

Does anyone know what is the latest status of these trials

[jeffreyn]

1. International stem cell corporation hpNSc trial

healthunlocked.com/cure-par...

[Farooqji in reply to jeffreyn]

thanks. This trial is very slow , probably not for us

[Hidden]

There’s also Blue Rock in the US that just started it is recruiting. Mass General not yet recruiting but claimed they would in fall or early 2022.

And intravenous at University of Texas

[jeffreyn in reply to Hidden]

intravenous at University of Texas

healthunlocked.com/cure-par...

[jeffreyn in reply to Hidden]

Blue Rock in the US

scienceofparkinsons.com/202...

[Farooqji in reply to Hidden]

Is there any timeline defined for the trial. I had read somewhere that FDA has given approval for this trial on fast track basis

[JAS9 in reply to Farooqji]

I tried signing up for the Texas trial but my diagnosis was over 10 years ago, so no go. They were recruiting last month, but had only 10 or so slots left. I got the sense that they were pushing to get going soon. Bad thing about that one is that they expect you to come to 11 sessions over 18 months, so it could get costly if you don't live nearby.

[jeffreyn in reply to JAS9]

I think Farooqji is referring to the Blue Rock trial.

" ... BlueRock Therapeutics announced that the U.S. Food and Drug Administration (FDA) has granted “Fast Track designation” for DA01 for advanced Parkinson’s ..."

scienceofparkinsons.com/202...

[jeffreyn]

There is also an ongoing stem cell trial in China that involves the intravenous infusion of umbilical cord [tissue] derived mesenchymal stem cells.

Estimated Primary Completion Date: October10, 2021

Estimated Study Completion Date: December 30, 2022

clinicaltrials.gov/ct2/show...

[Canddy]

Here is a link to the Texas Stem Cell trial from clinicaltrials.gov:

clinicaltrials.gov/ct2/show...

Trial end is expected in May 2023; if the study is not extended data should be available in Summer 2023.

Here is a link to the Blue Rock study that CC mentioned from clinicaltrials.gov:

clinicaltrials.gov/ct2/show...

Trial end is expected to end in January 2024 - data may be available prior to that date.

I expect stem cell therapies, if effective, are at least 5 (the absolute earliest) to 10 years out.

[Farooqji in reply to Canddy]

At least 10 years (my guess)

[Canddy in reply to Farooqji]

More than likely.........

[sharoncrayn in reply to Canddy]

listing in CT.gov is often meaningless. sorry.

if you do a historical search, you will understand how seldom results are ever published (meaning the CT went nowhere because it was halted or produce minimal non-SR results or the placebo did better than the intervention or the participants dropped out or AEs were too much).

Most phase 1 CT's aren't worth much anyway other than testing for mortality or cancer causing. the TX phase 1 is a good example of a human/cell biology study using nerve cells injected into the brain (PUTAMEN) followed by an immune suppressant drug with the minimal # of participants (10) in case they kill/harm somebody in the process.

Desperate beyond my comprehension, but just me.

sharon

[Canddy in reply to sharoncrayn]

Agree that often results are not posted and studies are stopped without notification if results are ambiguous or negative. Even if trials are positive clinicaltrials.gov is often not updated but the positive results make news headlines. I do think clinicaltrials.gov is a good window into what trials are being conducted (for Parkinson's Disease) at any given time. I don't know of any other "current" clinical trial database - do you? If you do know of a good clinical trial database can you please share? Many thanks!

[sharoncrayn in reply to Canddy]

There is no other US database for obvious reasons. who is going to fund it and why would they do so given the FDA?

the EU has their own CT Registry which often duplicates the US registry, but is far smaller.... so does Britain, Korea, and Japan. NIH has a specific database called CTDB.

I didn't realize you had a background in CTs. what is it exactly? where did you get your Phd? I describe my background in my profile...

sharon

[Canddy in reply to sharoncrayn]

I am one of those dreaded Big Pharma employees - upper management actually - 30 + years....

[sharoncrayn in reply to Canddy]

what can I say that is diplomatic? actually you have to weigh the good with the bad when it comes to pharma... it isn't all black or all white. pharmas produce, doctors prescribe, patients take. each step someone makes a choice.

CT.gov is seldom current or updated. look at it closely.

the PD media is often guilty of misrepresenting the CT results in a positive manner to garner more "hits". most of these CTs aren't worth reporting unless you love cell biology or have a house full of rats.

sharon

[Canddy in reply to sharoncrayn]

I don't disagree with the points you make especially regarding the PD media but we have to use the tools we are given and I will continue to refer to clinicaltrials.gov for information regarding clinical trials in PD. Thanks for engaging me in this discussion!

[jeffreyn in reply to Canddy]

When considering timeframes, there is a significant difference between therapies using iPSCs or hpNSCs (involves brain surgery), and therapies using MSCs (involves intravenous infusion).

[JAS9]

This is an update on that "Doc vs Parkinson's" clinical trial that's being run by Mass General. Some of this info is from their site, but the interesting bits are from a 'source' with some inside knowledge. I don't mean to be mysterious, but I don't think he'd appreciate being contacted by mobs of people. If you have a question, I'll try to get answers.

The first (human) subject continues to show improvements: "Two years after the surgery, imaging tests indicate that the transplanted cells are alive and functioning correctly as dopaminergic neurons in the brain. Because the implanted cells originated from the patient, they did not trigger an immune response and were not rejected without the use of an immunosuppressant drug."

About four years have now passed since the surgery, and the subject continues to improve "every day". His only regret is that he "only" had 5 million stem cells implanted. The new clinical trial, which should begin "soon", will evidently implant 25 million. Don't hold me to this, but I believe this is the plan.

The second trial will involve 10 more subjects (who have already been selected) and approval is expected within months (not years). The team has had to work through some issues involving the quality of the iPSCs for the trial, but they firmly believe that these issues have been dealt with. They resubmitted their proposal and now they wait while the FDA does their part.

If that trial goes well, they plan on a third human trial and may need more subjects (according to my 'source'). However, they won't know any details of this third study until the second (hopefully soon-to-begin) study has shown some positive results.

The team behind these trials has some confidence, given the results from the first trial, but they definitely do NOT want to over-promise or raise expectations too high. "We have a lot of work to do" is the general attitude.

So, everyone should be aware that these trials are happening but temper that hope with the reality that everything has to be 'FDA perfect'. On the other hand, these trials are being pushed along as quickly as possible since funding is apparently not an issue. Much of the funding is coming from a wealthy doctor/inventor, who was the subject of the first clinical trial. He's dedicated himself and his significant resources to helping as many PwP as he can. He knows first-hand how hard PD can hit, and he volunteered for - and funded - the first trial.

[Farooqji in reply to JAS9]

Thanks JAS9 for such a detailed information. This gives us some hope that things are going at good pace in t he background (although not publicized openly). Can you tell us where this trial is taking place and whether this trial is part of list that has come to surface so far in different news sources. I wish that the different organization carrying out stem cell trials in silos, come together and share knowledge with each other so that things are further speeded up

[JAS9 in reply to Farooqji]

Mass General is Massachusetts General Hospital. Here's a link to the press release (which is now 2+ years old): massgeneral.org/news/press-...

A more general link to how their tech works: massgeneral.org/neurosurger...

Here is a link to Dr Kwang-Soo Kim's page: parkinsonscelltherapy.org/k...