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Cell Therapy Companies Making Media Claims to Treat COVID-19

Authored by the CellTrials.org Team

 

We present a table that compares media coverage in the western hemisphere versus clinical trial registration for cell therapy companies that propose to treat some aspect of COVID-19. According to our CellTrials.org database of COVID-19 clinical trials through 15 April 2020, out of 44 cell therapy trials launched since the start of the pandemic, almost 40% have industry sponsorship. However, most of the cell therapy trials registered to date for COVID-19, as well as their sponsors, are in China. In the table below we focus on the cell therapy companies that are receiving attention in western media.

  • This table was assembled based on Google News searches on the keywords “cell therapy” (in English) through April. We do not claim this list is comprehensive, and it is a snapshot of a rapidly evolving situation.
  • For those companies with media coverage, we checked our CellTrials.org database to see if they have registered a clinical trial for COVID-19. Because this field is moving rapidly, we also looked online to see if the company announced that they had received approval for a trial from the relevant government agency in their country.
  • This sampling resulted in 17 companies or company partnerships.
  • The type of therapeutic cells is mesenchymal stromal cells (MSC) for 12 (70%) of the companies. A few companies are employing therapies based on immune cells (NK, T-cells), and one company employs a cardiac-derived cell line.
  • The MSC therapies rely on a wide variety of cell sources: bone marrow, adipose tissue, umbilical cord blood, umbilical cord tissue, placenta, and induced pluripotent cells.
  • Only 6 companies have registered clinical trials so far, and 2 are pre-pandemic trials that have been extended to treat COVID-19 patients.
  • We noticed that several companies started media announcements well in advance of the trial clearance by regulators.
  • We are presently in a period of upheaval where some companies are bypassing the normal procedures for IND approval and registration of clinical trials. Instead, they have obtained FDA Expanded Access (“Compassionate Use”) exemptions or have applied for the FDA’s new COVID-19 Emergency Use Authorizations (EUA).
  • Media reports indicate that several companies have entered clinical applications immediately upon receiving FDA approval, before registering their trial. This is reasonable and even desirable during a pandemic, but it makes it harder for us to track ongoing studies based on trial registrations.
  • Several publicly traded cell therapy companies have had big jumps in their share price simply by announcing plans to treat COVID-19.
  • We are starting to see media reports where companies announce preliminary study results via press release, oftentimes from the same companies that have not yet registered trials establishing the endpoint goals of their study.
  • All of these disruptions in the process of entering clinical studies and reporting results of clinical studies make it harder than usual to evaluate the actual benefits of the studies.

 

Company

Country

Cell Therapy

Trial ID /
Regulatory Status

Media Coverage
Example

AlloVir

US

Allo- Viral-specific T-cells

NO (preclinical)

Fierce Biotech

Athersys

US

Allo- BM MSC (Multistem)

NCT04367077

Yahoo! Finance

Caladrius

US

Auto- CD34+ hematopoietic cells (CLBS119)

IND cleared by FDA

Yahoo! Finance

Capricor

US

Allo- Cardiosphere-derived cells (CAP-1002)

NCT04338347

Yahoo! Finance

Celularity / Sorrento

US

Allo- NK from placental blood (CYNK-001)

NCT04365101

Fierce Biotech

Citius / Novellus

US

Allo- iPS cell-derived MSC

NO (preclinical)

Contract Pharma

Cynata

Australia

Allo- iPS cell-derived MSC (Cymerus)

NO (preclinical)

BioWorld

GreenCross Lab Cell

South Korea

NK cells

NO

UPI

Healios K.K.

Japan

Allo- BM MSC (Multistem)

NCT03807804 extend to COVID-19

Yahoo! Finance

Hope Biosciences

US

Auto- AT MSC
Allo- AT MSC

NCT04349631
NCT04348435

Contract Pharma

KangStem

South Korea

Allo- CB MSC (FureStem RA)

NO

Korea Biomed

Mesoblast

Australia

Allo- BM MSC (Remestemcel-L)

IND cleared by FDA

Yahoo! Finance

Orbsen

UK

Allo- UC MSC (ORBCEL-C)

NCT03042143 extend to COVID-19

Hospital Healthcare Europe

Personalized Stem
Cells
/ Calidi

US

Auto- AT MSC

Submitted EUA

EIN news

Pluristem

Israel

Allo- placental MSC (PLX)

Compassionate Use / Expanded Access

Seeking Alpha

Predictive

US

Allo- UC MSC (CoreCyte)

Submitted EUA

BioSpace

Stempeutics
/ Educell

India /
Slovenia

Allo- BM MSC (Stempeucel)

NO

BioSpectrum India