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

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.
 
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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.)
 
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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.
 
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".... !



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.
 
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