I am participating in the clinical trial of mesenchymal stem cells at Hope Biosciences in Houston, Texas. I am Patient 54 out of 60 they plan to enroll. I had my first infusion yesterday, with no obvious concerns or ill effects. As my treatments progress, I would like to privately compare notes with others in the trial.
If you are also in trial of mesenchymal stem cells for Parkinson's at Hope Biosciences, please send me a private message or comment below. Thanks!
Best wishes Jim
I have my first infusion today - hope it's not just the placebo. I created a Facebook Page to discuss this trial "Stem Cell Clinical Trial for PD"
I will look for your Facebook page and I will also send you a private message to begin a conversation. 🙂
hi I cannot find the group on Facebook for some reason. Would you please post a link. We are considering applying - we live in Israel and it would be a huge commitment for us which is ok but if my hubby gets the placebo and we need to do it again it would be too much. Can you please clarify what stems cells they are using. Wishing you all the best and a complete recovery
They already are full sadly. I was meant to be in the trial, but could not go because of a shoulder injury. I would really appreciate if folks would keep me in the loop as well. I'd like to keep tabs on how people are doing. But am not a fb fan.
Good for you, Jim.
How often do you have to trek down there?
Once a month for 7 months, including the initial evaluation. Two down, five to go.
As a veterinarian I used mesenchymal stem cells to treat ACL damage in canines. I used body fat and extracted stem cells. They worked well. The big concern here though is whether these stem cells cross the BBB. For me the stem cells were injected into the dog's knee (stifle joint). The stem cell rebuilt the torn ACLs.
Keep us updated on this blog. Do not run away. You ‘ll see it will go well. Thank you very much.
Keep us posted!
I would like to participate as well. Are there any studies near PA. That you might know of?
The first trial is only in Sugar Land. I hope that Penn or Jefferson in Philly will be sites next round!
Following
Good luck Jim!
I suspect in your next life you will be reborn as a pin cushion. Thank you for helping advance our understanding of new PD therapy possibilities. Is this the extension trial? Open label?What is the rationale for not going to phase 3? Did the original phase 2 show potential clinical benefits?
the level 2 clinical trial still had some positions open but may have filled up in the last few days- once someone starts the trial they are on a one year schedule. The first visit is a physical then 6 infusions about one month apart then two phone visits to see how the participant is doing. About one year after the initial visit the final physical is done so it may be a little over a year before the trial has been completed then it takes a while to tabulate all the results. The trial is designed for 60 participants with half getting stem cells and half getting placebo. This is likely how a trial needs to be set up to get FDA approval.
Thank you.
This is the most recent study listed on Hope's website - and it completed on 2023-03-06clinicaltrials.gov/study/NC.... I thought that was the trial you are describing.
clinicaltrials.gov/study/would appear to be an extension study - which I first thought Jim was on
clinicaltrials.gov/study/NC... looks like it's Jim's and it is controlled double blind. So Jim doesnt know whether he's getting drug or saline. But Hope's own website description of this trial makes no mention of a placebo and implies all participants get the drug
At some stage in the future the trial will be unblinded and Jim will know which one he had.
60 participants single centre phase 2 is to evaluate safety. It is not going to result in FDA approval. That would take a multi-centre phase 3 trial involving hundreds of participants
But, as noted above, Hope have already completed a phase 2 study. So why are they carrying out a further (possibly 2 further) phase 2 study, instead of going to phase 3 and FDA approval?
when I wrote this sentence
"This is likely how a trial needs to be set up to get FDA approval"
what I meant was that when Hope Biosciences set up the trial it was necessary for them to have a treatment group and a placebo group for the FDA to allow the clinical trial
The trial with 60 participants has not been completed and will not be completed for over a year because each particpant is enrolled for a one year period so even if the last few participants have now been approved to participate they will go through a year long participation in the trial before it will be completed.
Thanks. I think I am clear now where I got muddled. There appear to be 3 trialsNCT04928287 with 24 participants phase 2 which has completed and posted results
An open label extension study which appear to be to allow those in the placebo group on the original trial to get a treatment, and
A new 60 participant double blind placebo controlled phase 2 trial which Jim is number 54 on, and your husband an earlier number which will not complete and unblind until at least 1 year after the final recruit starts treatment and although still recruiting must be very close to full
So maybe 18 months before we know anything
There's an awful lot of data published in the results section of the first trial, and I am not qualified to properly interpret it, but as a very broad thought
There appeared to be more adverse events (one serious) in the drug group than placebo
Clinical improvement was not evident over 52 weeks (UPDRSII +1.2 for drug group was actually slightly worse than +1.11 for placebo)
So, maybe that's why they are doing more phase 2, and I mistakenly thought it was open label as a result of reading Hopes trial description instead of the government website🫢
"So, maybe that's why they are doing more phase 2"
This new (N=60) Phase 2 trial (NCT04995081) is using a different "technology" (allogeneic MSCs). So they needed to do a new Phase 2 before they could do a Phase 3.
Thanks, Richard! I'm not particularly optimistic, but I thought it might be worth a shot (no pun intended). I'm on the tail end of their phase two trial. It's double blinded. I have much greater hope in Bayer/BlueRock and Aspen, but neither of them are currently recruiting. I did have one of the best 9 hole rounds of golf in my life today, so maybe there's something to this. 🏌️😛⛳
I need to get on that trial Jim. I haven't played golf in 8 years. Played 9 holes in Portugal on a wedding trip (my stepson now works for a golf travel company) and 18 holes at Carcassonne and couldn't break 100. Hit some blistering drives but couldn't chip or putt for love nor money. I'll do some serious practicing when I get back from holiday
All the very best to you Jim, and good luck to all the participants. Look forward to hearing how it’s going.
Great start Jim! Talk soon
I hope you see improvements! I would love to hear how it goes. Best of luck.
I wish you the very best outcome, Jim.
Hi Jim,
I think you may find the following link interesting in relation to your mesenchymal stem cell transplantation( MSCT) :
ncbi.nlm.nih.gov/pmc/articl...
Here are two relevant quotes from the link :
' Melatonin interacts with various types of stem cells, in multiple ways that comprise stimulation of proliferation, maintenance of stemness and self-renewal, protection of survival, and programming toward functionally different cell lineages. These various properties are frequently intertwined but may not be always jointly present. Melatonin typically stimulates proliferation and transition to the mature cell type. For all sufficiently studied stem or progenitor cells, melatonin’s signaling pathways leading to expression of respective morphogenetic factors are discussed. The focus of this article will be laid on the aspect of programming, particularly in pluripotent cells. This is especially but not exclusively the case in neural stem cells (NSCs) and mesenchymal stem cells (MSCs). '
' The participation of melatonin in programming, maintenance of self-renewal, and proliferation of stem cells is now beyond doubt. '
There are many studies that discuss the value of melatonin when it come to MSCT and it may be worth researching some of those since you are now in the process.
One way to further increase your melatonin levels above your current oral intake is via melatonin lotion which I wrote about here :
healthunlocked.com/cure-par...
Art
Best of luck to you! I’m in Pittsburgh PA. If you hear of this being available here I’d appreciate the information. Thanks
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