July 10, 2020

The Niche

Knoepfler lab stem cell blog

COVID-19 cellular medicine buzz: Mesoblast, FTC hammer, more

EM of Novel Coronavirus SARS-CoV-2 that causes COVID-19

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

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