Closed USA, Texas - Long Covid stem cell trial - Hope Biosciences

https://twitter.com/user/status/1659258095544016896

 

I am quite surprised this is legal.
It isn't a drug it is some cells.
They presumably aren't matched so are likely to produce graft rejection.
There is absolutely no reason why they should help.

 

I hadn't noticed that this is being promoted by Solve ME. What the hell do they think they are playing at? I thought they were supposed to be a charity encouraging scientific research.

 

It’s an “investigational drug product” !

 

I lost faith in their standards when the ceo hosted a chat with Bruce Patterson of Incelldx.

 

How very Texas.

 

You should be so lucky, @Trish - they could well give you graft versus host disease if they are really stem cells. Fortunately in Texas everything is fake (except the 64 ounce steaks) so maybe not.

 

FDA notice to consumers which was valid thru June, 2020 . No approved use of stem cells except from umbilical cord blood.

https://www.fda.gov/vaccines-blood-...ne-products-including-stem-cells-and-exosomes

Regenerative medicine (woo-ish) or stab in the dark (because of PASC?) again. The foundation had a previous trial lasting a year (2022) using autologous stem cells (the patient's own).

The clinical trial : https://clinicaltrials.gov/ct2/show/NCT05126563?term=stem+cEells&cond=Post+COVID-19+Condition&cntry=US&state=US:TX&draw=2&rank=2

ETA: I sent off an email inquiry to the FDA with my concerns about whether this is a legitimate study.

 

From the Solve ME Facebook page:

"Solve is hosting the Hope Biosciences Research Foundation (HBRF) for a webinar on Thursday, May 25 at 10AM PT. HBRF has conducted three FDA-authorized studies in mesenchymal cell therapy for #COVID19 prevention and treatment, and two studies in #LongCovid.
Register: http://ow.ly/3UGV50OqA1b" (Facebook redirect)
Direct link to registration: https://us02web.zoom.us/webinar/register/WN_MOj-pl8mTnCl4jB1Oo7eSA#/registration

 

The FDA branch for biologics CBER responded to my email. They can't comment on an investigational new drug (IND) which I assume is Hopebio's currently recruiting clinical trial.

FDA's CBER said I can only ask the Sponsor of the study if the trial is conducted under a IND application and ask them for the FDA clinical trial IND number. Then I can ask the FDA if the number is correct and current.

Hopebio's website has the FDA-assigned clinical trial number posted.

FDA-CBER did say that if I had a complaint about the trial, I should contact them. I assume this means that if I were a participant-subject and had adverse events, CBER wants to know. Or if the methods seemed unsafe, unsanitary, etc.


Ho hum. Caveat emptor. Buyer beware. (It is a phase-II study so the sponsor is assessing for safety issues.)

 

Here's the webinar on YouTube:

https://www.youtube.com/watch?v=Ny2B8K1k8ZM

 

Success they say

https://twitter.com/user/status/1662114866004410373

 

I did not watch the webinar.

But I know a thing or 2 about allogenic stem cell infusions from my past professional life.
1- the person receiving the infusion on day 1 will find out whether they receive cells from another human or only the saline infusion. That is because the chances of infusion reactions (hives, difficulty breathing, stopping breathing, anaphylactic shock) would be high.
2- as @Jonathan Edwards mention, the ‘graft vs host’ reaction can be severe and prolonged, which means you can have full organ shut down because there are non-self circulating cells in the body. Stem cells, they will want to ‘implant’ and stay, which is likely to wreak havoc to any organ, including skin forever.
3- the clinical trial.gov website for this trial mentions very few objective endpoints, and many visual analog scales, meaning it heavily relies on patient subjective outcomes.

I too worry that Solve ME got into this mess. post #1 mentions allogenic stem cells and post #13 mentions autologous (own cells). It is a huge difference, but even autologous can cause issues in the trial if you don’t know what you’re doing and why.

 

I'm going to second everyone else's concerns. Stem cells have just one proven application, and there's a lot of quacks out there claiming they're a cure-all. It's fairly unlikely this will lead anywhere.

 

It looks as if it was autologous - you get your own cells back.
You might as well take blood out of your left arm and infuse it back in the right arm as far as I can see.

And it looks uncontrolled?

 

The mind just boggles. this from Solve?

honestly, between the BPS nonsense on one side and this sort of thing on the other, it makes me think of Stealers Wheels. I mean really.... talk about "Clowns to the left of me jokers to the right".... !

https://www.youtube.com/watch?v=ln7Vn_WKkWU

for those who dont know the song / cant watch video heres a few choice lyrics

Well I don't know why I came here tonight,
I got the feeling that something ain't right,
I'm so scared in case I fall off my chair,
And I'm wondering how I'll get down the stairs,
Clowns to the left of me, Jokers to the right,
here I am, Stuck in the middle with you.

...

Trying to make some sense of it all,
But I can see that it makes no sense at all,
Is it cool to go to sleep on the floor,
'Cause I don't think that I can take anymore
Clowns to the left of me, Jokers to the right,
Here I am, stuck in the middle with you.

 

Please explain.

 

Dunno, just seems a bit Outlaw Medicine, Dallas Buyers Club, isn't it?