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

Thanks for explaining.

 

About stem cell therapy risks, stem cells from other people and babies

https://www.pewtrusts.org/en/resear...ns-highlight-need-for-greater-fda-enforcement

 

Results just released, not great.

https://www.businesswire.com/news/h...-of-Cell-Therapy-Clinical-Trial-in-Long-COVID

"The trial enrolled 79 participants, with 39 subjects in the treatment group and 40 in the placebo group; 34 participants completed the study from the treatment group, and 30 from the placebo group. The 26-week study mandated four infusions of 200 million stem cells, for a total of 800 million cells. The primary endpoint was a visual analog scale (VAS) test for fatigue, in which 68% of subjects in the treatment group showed significant improvement (p=.0002) and 63% of subjects in the placebo group showed significant improvement (p=.001). Differences between the treatment and placebo groups were not statistically significant. Treatment was safe and tolerable in both groups. Detailed analysis is now underway."

"An unexpectedly high placebo effect was observed, masking the treatment effects, with both groups exhibiting significant improvements. This unprecedented placebo response suggests a need for further investigation.”

Was there an unexpectedly high placebo effect or do most Long Covid patients gradually improve over time?

 

So taking cells out of your left arm and putting them in the right does nothing, as expected.
There is no way this is a 'placebo response making a treatment effect. Even with a big placebo response a meaningful treatment effect would shift the figures more than this.

 

Hope biosciences just tweeted:

“200 million HB-adMSCs are packaged in 20ccs of saline. They are then suspended into a 250cc saline bag for intravenous delivery. The placebo is the same minus the cells”

 

It could be the 250ccs of saline that contributed to improvement (although I would think that would only be temporary). Do we know how often the infusions were or when the endpoints were taken?

 

The saline and generally the fact a decent chunk people with long covid get better with time.

 

Four infusions and end-points were taken several weeks after infusions (infusions took place till week 10 and end of study visit occured at week 26). In any case it seems clear that these stem cells do nothing in such a heterogeneous cohort and I doubt that, that has anything to do with saline somehow being beneficial.

The main goal of the trial was to asses anti-inflammatory and immunomodulatory properties, since those weren't reported in the press release they probably didn't identify any.

Note that people were able to participate in this trial as long as they had a diminished sense of smell for 12 weeks. These type of trials really make very little sense to me.