New Stem Cell Trial in Houston Recruiting

[Bolt_Upright]

Looks like there my be more than one stem cell trial for PD recruiting. The PD trials seems to have placebo arms (not a fan of trials with placebo arms).

hope.bio/clinical-trials

[Boscoejean]

what are placebo arms?

[Juliegrace in reply to Boscoejean]

It means the trial is blind and the participants don’t know if they have the actual treatment or placebo.

[Boscoejean in reply to Juliegrace]

Thank you. We contacted them and they sent us the information but it is a bit complicated because we do not live near the study site and the idea of multiple plane trips while covid is still a problem is another issue.

[amykp]

Re placebo arms--Haven't even looked at the trial yet but I want to say I couldn't agree more with you bolt, and I wish PD patients would band together and do something about it.

Of course placebo arms are important, I get that. But all the study needs to do is offer everyone the real drug at the end, or a switch, or some such.

I was in the Genzyme-Venglustat study, and one of the reasons I agreed to participate was that after a year of 50/50 drug/placebo, it was "all on" for two more years.

As it happens, the drug failed, but that's not the point. Everyone got to try it.

Before you agree to be in a trial, ask!

[Bolt_Upright in reply to amykp]

That is a great point! If they offer you delayed stem cell treatment if you get the placebo, then it probably is still a fair deal.

[amykp in reply to Bolt_Upright]

Yeah, so how do we (as patients, and really, not just PD patients) advocate for that? It's something I've been stewing about for a while.

[amykp]

BTW, here is something I don't understand about these (and most) dopamine-stem cell treatments. If they are not injecting the stem cells into your brain, specifically into the substantia nigra (which is the part that is missing them) then how the heck are they working?

And if they are autologous (from yourself) are they culturing them first, turning them into working dopamine neurons?

And if this treatment DOES work, why did they bother with all the fanfare and rigamarole over at Mclean hospital (they "turned" autologous fat cells into dopamine stem cells and implanted them in the brain of one man). and made a big fuss like it was the first time and best thing ever.

mcleanhospital.org/news/nov...

I mean, to me, this sounds hopeful and great, but it makes all this other stem cell stuff seem kinda nutty.

[Bolt_Upright in reply to amykp]

I hope this study is injecting into the brain.

The reason there is much fanfare about multiple strategies is there are a multitude of teams working in parallel on different strategies. This is good as not everything will work on everyone, and also, different strategies may benefit different symptoms (although I hope one infusion of stem cells fixes everything for everybody!).

[amykp]

From reading their stuff, I THINK they are not.

[Following_closely]

Bolt and Amykp,

They did inject into the brain. Twice. Here's the complete abstract:

"We report the implantation of patient-derived midbrain dopaminergic progenitor

cells, differentiated in vitro from autologous induced pluripotent stem cells (iPSCs),

in a patient with idiopathic Parkinson’s disease. The patient-specific progenitor

cells were produced under Good Manufacturing Practice conditions and characterized

as having the phenotypic properties of substantia nigra pars compacta neurons;

testing in a humanized mouse model (involving peripheral-blood mononuclear

cells) indicated an absence of immunogenicity to these cells. The cells were implanted

into the putamen (left hemisphere followed by right hemisphere, 6 months

apart) of a patient with Parkinson’s disease, without the need for immunosuppression.

Positron-emission tomography with the use of fluorine-18-L-dihydroxyphenylalanine

suggested graft survival. Clinical measures of symptoms of Parkinson’s

disease after surgery stabilized or improved at 18 to 24 months after implantation.

(Funded by the National Institutes of Health and others.)"

The article you quoted earlier says that the patient contributed money, which is one way to make sure you're treated(!) I can understand not wanting to be the recipient of a sham stem cell implantation, which would involve a skin biopsy and a sham brain surgery. However, there's a reason that the gold standard for clinical studies is a double-blind trial (where there is a placebo group and neither the patient nor the medical personnel observing them know who got the treatment and who got the placebo). I think it's even more important for PD because the placebo effect can be especially strong in a disease where the problem is too little dopamine and it may be possible to produce more dopamine for at least a time just through feeling hopeful.

I think part of the big deal is that the study reprogrammed fibroblasts, which are easy to get (a skin biopsy rather than bone marrow or something else requiring more invasive procedures), they're easy to maintain in culture, and as mentioned in the abstract, since they come from the patient, they don't incite an immune response, so the patients don't require immunosuppressive drugs.

[Bolt_Upright in reply to Following_closely]

I'm confused. Is this abstract from the Hope Biosciences trial or from the Mclean Hospital trial? Could you please share the link?

[Following_closely]

This is from the Mclean trial. I thought that's what you were discussing. Here's the link to the abstract and the free version of the article:

pubmed.ncbi.nlm.nih.gov/324...

[Bolt_Upright in reply to Following_closely]

Yes, Mclean was transcranial. Amazing story.

[Baron1]

Good Morning,

Any feedback or interest in the Stem Cell company in Houston Texas "CellTex".

I have read some information but trust others may have looked at CellTex as well out of interest.

Would be good to gauge whether anyone has ventured to see them, and what experiences that had with the company.

[Bolt_Upright in reply to Baron1]

This is not an endorsement. Just something I found:

CELLTEX NEWS: How Stem Cell Therapy Helps Retired Coach Mark Richt Manage His Parkinson’s Symptoms celltexbank.com/blog-parkin...

I found this also: How is Mark Richt doing with Parkinson's?

Now, two years later, Richt says he's managed to keep his Parkinson's disease (PD) symptoms at bay through a regimen of insulin infusions, stem cell therapies, and, recently, Levodopa. He also makes sure he exercises, gets enough sleep, and eats well.Apr 12, 2023

So it does not look like he has stopped progression if he recently started Levodopa. I could be wrong, though.

[Baron1 in reply to Bolt_Upright]

Good Morning,

Thank you for the reply.

However, what baffles me in respect to patients claiming that they see some sort of benefit, is that each company claiming to be using Mesenchymal Stem Cells state they have treated thousands of patients.

If so, why are there not more patients coming forward to express their joy of improvement in their health and condition.

Even if some maybe a placebo effect, still if a clinic is stipulating treating thousands of patients, in the 21st century people are more prone to profess their excitement of how they are feeling better due to some type of treatment.

However there is little growth in numbers of people's stories of success with stem cells.

I have read numerous amount of trials showing some benefits, but these are trials and they would be ensuring that their product is genuine and not watered down so to speak.

Still the world at large does not have enough individuals going on line and or to the media and staking their claim of stem cells benefiting them.

I recently contacted the Stem Cell clinic in Japan and have finally got an answer on costs. I could not believe the fees. For 200 million Meschenymal Stem Cells from your own body fat cost $20,000 USD and they recommend bi-monthly treatments of a total of 10 overall. That equates to $100,000 USD. I believe that this is way, way too expensive for an unproven treatment.

That is why I am trying to find out if any reputable clinics with proven results of some substance are out there. Again not enough positive reviews for any clinic to stand out, just professional actors, or sports people or maybe even paid individuals making claims of benefits. To me, many of the people online who are attached to one of the clinics may have been paid to make the claim that they have benefited from stem cells.

The clinic studies have shown that a person requires several intravenous treatments quite close together for any real benefit, not a one of treatment, as most of the stem cells will not have achieved anything, even with their pay load exosomes with them. It requires continual top ups to assist a persons body to adapt and show some form of improvement.

One study I read stated that stem cells (depending on size) will not reach the brain and the percentage that does would be estimated around 20% at best because of several factors; mainly the blood brain barrier. They also made reference to even though they are a persons own stem cells from fat tissue, they are still old and not juvenile stem cells as they have not been reprogrammed as such which can be done through another process.

They went on to state that because of the stem cells being old and not young, was one of the reasons that they are not returning patients feeling and body composition back 10 to 20 years; as they are not young stem cells.

I will keep looking though.

[Bolt_Upright in reply to Baron1]

Yes, I don't have much faith in stem cells that are not placed into the head.