Authored by Mayasari Lim, Ph.D.
Industry sponsored MSC-based clinical trial activities for COVID-19
As of this writing, more than a dozen companies and groups have announced their interests to develop mesenchymal stromal/stem cell (MSC) based therapies to treat COVID-19 induced destructive lung conditions and diseases such as Acute Respiratory Distress Syndrome (ARDS). Among them, six have initiated or are already in clinical trials. In an effort to keep everyone abreast with the most recent developments, we are closely monitoring activities in the growing interest of developing MSC based therapies for COVID-19 and will continue to update this post over time.
Who’s in the race?
Here is a condensed list of key players offering and/or developing MSC therapies for COVID-19, including a link to their respective announcements:
Athersys (Cleveland, OH) received Fast Track designation from the FDA for its cell therapy candidate, MultiStem, to treat COVID-19 ARDS. Prior to COVID-19, MultiStem was already in FDA Fast Track status and RMAT designation for ARDS, accompanied by a one-year quality of life follow-up from the Phase II study.
Cynata Therapeutics (Brisbane, Australia) is currently in preclinical development for COVID-19 related conditions. Cynata’s Cymerus technology platform focuses on iPSC derived MSCs as cell therapies. The current large animal study to be done on sheep investigates the use of Cymerus MSC to treat ARDS in combination with extracorporeal membrane oxygenation.
Hope Biosciences (Sugarland, TX) announced on Apr 6 that it has received FDA approval for a Phase II clinical trial evaluating safety and efficacy of their autologous, adipose-derived MSCs (HB-adMSCs) to COVID-19 patients. This trial will recruit 75 patients that are either 50 years of age, have pre-existing health conditions or are at high-exposure risk. Results from their recent Phase I/II clinical trial for Rheumatoid Arthritis show that HB-adMSCs were safe and effective in attenuating systemic inflammation. Hope Biosciences recently received the 2nd FDA approval for a Phase II trial for an allogeneic therapy to provide immune support against COVID-19.
Mesoblast (Melbourne, Australia) announced on Apr 5 that the company received FDA IND clearance for the use of Remestemcel-L in patients with COVID-19 induced ARDS. Remestemcel-L is a bone marrow MSC product candidate that will be intravenously infused into patients with COVID-19. Remestemcel-L has been successful in Phase III trial for steroid-refractory acute graft versus host disease (aGVHD) in children which presents a similar cytokine storm process as those observed in COVID-19.
Over the past few months, early clinical data from trials conducted in China and Israel have been reported based on the observations made in COVID-19 patients treated with MSCs and these include:
A Chinese group reported improved outcomes in patients with COVID-19 pneumonia that were treated with ACE2- MSCs in Beijing YouAn Hospital. According to the authors, pulmonary function and symptoms of the 7 patients significantly improved in 2 days after MSC infusion. No adverse events have been reported and 3 out of 7 patients were discharged in 10 days after treatment. This report was published in Aging and Diseases.
Pluristem Therapeutics (Israel) announced on Apr 7 that its PLX cells, a placental derived expanded MSCs, are showing positive signs such as respiratory improvements in 4 out of 6 patients with severe symptoms of ARDS. All 7 patients in this study survived and no adverse events have been reported. Read the company preliminary data report here.
In the coming months, we can expect to see more clinical data from various groups who are starting to advance into their clinical trials here in the US.
Put your best foot forward
With the entire world weathering COVID-19, these are truly unprecedented times calling out to each individual and company to put their best foot forward. Here we are, witnessing perhaps for the first time, a concerted effort in the cell therapy field to bring their best plans forward to fight this disease. As these clinical trials develop, we are hopeful to see positive outcomes from each effort. Maybe not everyone will succeed but failures can still be a great learning to move this field forward.
Albert Einstein once said “In the midst of every crisis, lies great opportunity.”
And so here we are. Opportunities such as FDA’s Coronavirus Treatment Acceleration (CTAP) program and BARDA opportunity are being presented to mediate this crisis. Despite what your position or strategy might be, it is imperative to ensure that safety to patients must never be compromised. As a company that desires to fuel the rapid commercialization of scalable regenerative cures, this is really the foundation of our CliniControl™ products where quality begins at inception.
If you would like to learn more about how hMSC and scalable cell manufacturing will play into a rapid COVID-19 pandemic response, check out our COVID-19 resource page.