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The US Food and Drug Administration (FDA) has approved Hope Biosciences’ third clinical trial to assess mesenchymal stem cells for treating hospitalised Covid-19 patients.
This Phase II trial will be performed in alliance with Advanced Diagnostics Healthcare (ADH) at River Oaks Hospital and Clinics.
MSCs are known to possess immunomodulatory and regenerative properties, which are expected to help fight the inflammation and lung degeneration associated with severe Covid-19.
In the latest trial, 110 hospitalised patients with severe Covid-19 symptoms will be given Hope Biosciences’ adipose-derived mesenchymal stem cells (HB-adMSCs) along with current standard of care.
Study results will validate the role of HB-adMSCs in reducing the severity of Covid-19.
The randomised, placebo-controlled, double-blind, single-centre study includes two separate arms. It will randomise participants who are receiving or not receiving hydroxychloroquine plus azithromycin into a treatment or placebo group.
Treatment group will receive four doses of 100 million HB-adMSCs over ten days. The trial is completely sponsored by the Hope Biosciences Stem Cell Research Foundation.
Hope Biosciences founder and president Donna Chang said: “Our goal is to keep severely ill patients from needing invasive mechanical ventilation. We know that the probability of survival greatly decreases once a patient is invasively ventilated for this disease.
“Providing HB-adMSCs will help the patient’s immune system resist the damage associated with Covid-19 and aid in repair. If we can prevent patients from needing ventilators, we can increase the probability of survival.”
The company’s first two Covid-19 trials are focused on preventing the infection.
Chang added: “We chose to include patients with minimal respiratory support to those who have acute respiratory distress syndrome (ARDS) and require invasive mechanical ventilation.
“Through our three protocols, we will study the entire timeline, from the stage of susceptibility to subclinical stages to the most severe clinical manifestations of this condition.”