Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient. Image captured and color-enhanced at the NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland.
It’s been a busy week for the cellular and regenerative medicine space for COVID-19 news with some possible ups including for Mesoblast and some definite downs. Starting with the more positive media buzz with have Mesoblast.
Mesoblast made COVID19 news
“Thinly traded Mesoblast Limited (NASDAQ:MESO) rockets 51% premarket on average volume in reaction to its announcement of an 83% (n=10/12) survival rate in ventilator-dependent COVID19 patients who were treated with its allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days. Nine of the 10 were weaned off ventilator support after a median of 10 days, while seven have been discharged from the hospital.
By comparison, 9% (n=38/445) of ventilator-dependent COVID19 patients at a major New York City hospital who received standard-of-care treatment were able to discontinue ventilator support. The survival rate was only 12% (n=38/320) in ventilator-dependent COVID19 patients at another major hospital in the city.”
It’s stock was up more than 2-fold on Friday. How much weight should we put on these data? With only 12 patients and no controls, there’s not much to go on. That “83%” number is getting a lot of attention but there is little definitely relevant context to interpret that.
Look for data from larger, controlled work in the coming months.
Athersys and others are also pushing ahead. Also note that Capricor got compassionate use authorization for severe COVID-19 for its cell therapy.
The FTC took a hammer to marketing of unproven therapies for COVID-19 including 4 letters to firms marketing stem cells:
- “Absolute Health Clinic. Based in Olympia, Washington, the business has promoted its products and services by representing, “Did you know our clinic [has] . . . treatments available to treat COVID-19? . . . available treatments include . . . high doses of Vitamin C and D through IV therapy, and Stem Cell Therapy.”
- American Medical Aesthetics. According to marketing materials promoting the Los Angeles company’s products and services, people with COVID-19 have been “Cured with Ozone” and that treatments with “Mesenchymal Stem Cells” have been shown “to successfully treat the patient and reverse the illness.”
- Center for Regenerative Cell Medicine. The FTC says the Scottsdale, Arizona, company has promoted its products and services by claiming on its website that “Mesenchymal stem cells are a viable option in new coronavirus infection treatment” and that stem cell therapy has “successfully treated” a COVID-19 patient.
- Stemedix, Inc. “While experts are diligently working on vaccines and drugs, one surprising treatment has demonstrated efficacy for combatting [coronavirus]: stem cell therapy.” According to the FTC warning letters, that’s just one claim the Florida business has used to promote its products and services.”
The FTC letter to Stemedix got covered by The Tampa Bay Times too.
One headache is that the media exuberance over some legit biotechs working with MSCs or other related cells is potentially indirectly somewhat feeding this kind of marketing by unproven MSC and other clinic firms.
Other regulatory news
- Kimera labs got an untitled FDA letter for marketing and use of unproven exosomes including apparently in a COVID-19 patient.
- Predictive Technology Group ($PRED) had its stock suspended for its COVID19 testing claims. Predictive’s stem cell claims stirred controversy last year.
This kind of situation was perfectly foresseable when Trump started to push his “Right to Try”.
notwithstanding the fact that thevery president of the USA insisted on the potential efficacy of BAL with dettol or Mr. Clean or bleach or you name it, or, UV irradiation with bronchoendoscopy.
FDA authorising clinical trials without regards as to the very scientific foundation of many of the “cell therapies”: with political power in his hand, Trump puts his stiiges at the head of some agencies, and this is nothing new.
Financial interests in cell therapies? At least his attorney does have some when we lookat how he pushes his CAR-NK saying it may be the miracle cure for COVID-19. Now we don’t hear much about chloriquine from Trump who ridiculously pushed it.
What will become of those falsely claimed panacea made of cell injection, only the future will tell how much harm it will have made.
And yet if you bothered to read the whole article you would find Mesoblast’s remarkable results! Surely they and others are worth the price of a few quacks who are with us always!
The ‘remarkable’ results leave a lot to be desired. With COVID-19 being so varied, especially with its most sever outcomes, a N=12 is nearly unusable in terms of comparing to a non-controlled experiment. If it were a few quacks I might agree, but its been a ‘Quack’ epidemic for a while now with hundreds if not thousands peddling untested/unproven/dangerous ‘stem’ products.
Bottom line is that there needs to be a LOT more data before we can even begin to think in terms of efficacy.