Stem cells as treatments

Hutan

Hutan

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American Cryosystem Corporation is running a trial
"Treatment of Long COVID Utilizing Autologous Stem Cells"

The details are here on Clinical Trials.
Both the treatment arm and the placebo arm will have fat cells removed by liposuction. Later the treatment arm will have 150 million cells of expanded autologous lines (ATCell™) will be injected at one time; the placebo group will have a placebo injected.

There will be 20 participants, 10 in each group. After 4 weeks of followup, the placebo group will have the opportunity to have the treatment.

Estimated study start date is April 2023. Estimated end date is Dec 2023.

The primary outcome measures are extensive:
Assessment of change SF-36 at 4 time-points (the weeks after treatment)
Assessment of change a Six-minute Walk Test at 4 timepoints
Assessment of change in lab tests at 4 time points:
complete blood count with differential (CBC with diff), lactate dehydrogenase (LDH), prothrombin time/partial thromboplastin time (PT/PTT Coagulation factors II), Troponin, D-dimer, Fibrinogen (Coagulation factors II), estimated glomerular filtration rate (eGFR), Urinalysis and spot protein creatinine

I make that at least 44 primary outcomes.

There are also secondary outcomes:
Assessment of Changes in Exosome/Cytokine/Chemokine Testing at 4 time-points
The exosomes and cytokines and chemokines to be tested are not specified.
 
American Cryosystem Corporation were sent a warning letter by the FDA in 2018 specifically about Atcell:
The U.S. Food and Drug Administration today posted a warning letter issued to American CryoStem Corporation of Monmouth Junction, New Jersey, and its Chairman/Chief Executive Officer, John S. Arnone, for marketing an adipose derived stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that raise potential significant safety concerns, putting patients at risk.
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@Denise posted about an interesting 2019 article Statnews
Stem cell clinics co-opt clinical-trial registry to market unproven "therapies", 2019, Boodman Statnews

Unfortunately the article is paywalled, but it starts with
On the one hand, the Food and Drug Administration issued a letter stating that what an Arizona distributor was selling as stem cell therapies were “unapproved” and posed “safety concerns.” On the other, a National Institutes of Health database — clinicaltrials.gov — went right on listing the same merchant’s studies, with a link to the company’s website and the word “Recruiting” displayed invitingly in green.
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I'm not sure if that is referring to American Cryosystem Corporation or another seller of stem cell therapies.

I recall people with ME/CFS, I'm not sure if it was on this forum, or before on Phoenix Rising, trying to decide whether to spend an enormous amount of money on stem cell treatment.

I don't know if stem cell treatment for Long Covid is different now, but this has markers of being a scam treatment.
 
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The study said:
There will be 20 participants, 10 in each group. After 4 weeks of followup, the placebo group will have the opportunity to have the treatment.
Click to expand...
This destroys any possibility of medium-term assessment, let alone long-term. In a long-term condition. Come on we need professionals to do better than this. You only do that when a treatment is simply too effective after an initial assessment, you certainly don't put it as part of the protocol.
 
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