Hope Biosciences announces third FDA-approved clinical trial for COVID-19

Hope Biosciences announces FDA approval on their third clinical trial for COVID-19.

This study will be conducted in collaboration with Advanced Diagnostics Healthcare (ADH) at River Oaks Hospital and Clinics. The hospital has an entire floor dedicated to treating COVID-19 patients, with staff specifically trained to care for these patients. The goal of this collaboration is to provide cutting-edge therapeutic interventions, like Hope Biosciences’ adipose-derived mesenchymal stem cells (HB-adMSCs), in a safe, efficient environment to provide the best care to COVID-19 patients.

Hope Biosciences’ proprietary core technology delivers high-quality, fully characterized, fresh mesenchymal stem cells, on-demand. MSCs are well-known for their immunomodulatory and regenerative potential. These characteristics make them a potential therapeutic option to fight the inflammation and lung degeneration that is known to occur in severe COVID-19 patients. In this study, patients suffering severe symptoms associated with COVID-19 will have the opportunity to receive HB-adMSCs, in addition to current standard of care. The data generated in this study will determine the role HB-adMSCs may play in decreasing the severity of illness from COVID-19 infection. "Our goal is to keep severely ill patients from needed 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," said Donna Chang, Founder and President of Hope Biosciences.

This Phase II study is a randomized, placebo-controlled, double-blind, single center study that is expected to enroll 110 hospitalized patients into 2 separate arms. Participants taking hydroxychloroquine and azithromycin will be randomized into a placebo or treatment group. Likewise, patients not taking hydroxychloroquine and azithromycin will also be randomized into a placebo or treatment group. Those receiving treatment will receive 4 doses of 100 million HB-adMSCs over a 10-day period.

Hope Biosciences’ first and second FDA approvals for COVID-19 are focused on prevention while this trial is for patient treatment. "We chose to include patients with minimal respiratory support to those who have acute respiratory distress syndrome (ARDS) and require invasive mechanical ventilation. The broad range is not your typical study design, but for COVID, we felt that it was necessary to look at all stages of the disease. 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," said Donna Chang.
 

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