Celltex & COVID-19 Clinical Trials
Currently, Celltex has three ongoing COVID-19 clinical trials using its proprietary MSCs.
In Mexico, Celltex sponsors a COVID-19 Phase III clinical trial with Hospital Juarez, the primary government hospital in Mexico City, to treat patients with severe COVID-19 symptoms. Celltex was chosen as the exclusive provider of allogeneic (donor) MSCs for this trial and the trial has been authorized by COFEPRIS, Mexico’s equivalent to the US FDA.
In the US, Celltex sponsors a COVID-19 Phase II clinical trial that investigates the efficacy of autologous (one’s own) MSCs for preventing COVID-19 in high-risk individuals. The Company also sponsors a second COVID-19 Phase II clinical trial that investigates the efficacy of allogeneic (donor) MSCs for treating severe COVID-19 symptoms.
These clinical trials are important because it has been shown that severe COVID-19 causes cytokine release syndrome, or CRS, an acute systemic inflammation resulting in multiple organ failure including heart, liver, kidney, lung and other organs. CRS is a life-threatening complication with a high death rate if the patient is not treated quickly and effectively.
The safety and efficacy of MSCs have been demonstrated in many clinical trials and Celltex-produced MSCs have been used in over 9,000 therapies with no adverse reactions. The immunomodulating and anti-inflammatory properties of MSCs are crucial to strengthening the body’s defense system and combatting COVID-19. In an editorial written by Dr. Ashok K. Shetty, Associate Director at Texas A&M University Institute for Regenerative Medicine, it is shown that intravenous MSC infusions could reduce the over-activation of the immune system and support repair by modulating the lung microenvironment after COVID-19 infection.
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