The company has partnered with Advanced Diagnostics Healthcare (ADH) at River Oaks Hospital and Clinics to conduct the clinical trial
FDA approves Hope Biosciences’ third COVID-19 clinical trial. (Credit: Daniel Roberts from Pixabay)
US-based biotechnology firm Hope Biosciences has secured the US Food and Drug Administration (FDA) approval for its third clinical trial on COVID-19.
The company has partnered with Advanced Diagnostics Healthcare (ADH) at River Oaks Hospital and Clinics, which has dedicated an entire floor to treat COVID-19 patients, to conduct the clinical study.
The collaboration is aimed at providing advanced therapeutic interventions, including the company’s adipose-derived mesenchymal stem cells (HB-adMSCs) for COVID-19 patients.
The company’s core technology would deliver high-quality, fully characterised, fresh mesenchymal stem cells, with immunomodulatory and regenerative capabilities. MSC would serve as a therapeutic option against inflammation and lung degeneration, found in severe COVID-19 patients.
Hope Biosciences founder and president Donna Chang said: “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.”
The Phase 2 clinical trial that will enrol 110 patients suffering from COVID-19 symptoms
Hope Biosciences said that its first and second FDA approved COVID-19 trials are focused on prevention of the disease, while the third trial is aimed at patient treatment.
The Phase 2, placebo-controlled, double-blind, single-centre clinical trial that will enrol 110 hospitalised patients suffering from severe symptoms associated with COVID-19, randomized into 2 separate arms.
Patients on hydroxychloroquine and azithromycin will be randomised into a placebo or treatment group, while patients not taking hydroxychloroquine and azithromycin will also be randomised into a placebo or treatment group.
The patients in the clinical trial will receive HB-adMSCs in addition to their current standard of care, and the study data will be used to determine the role of HB-adMSCs in decreasing the severity of illness from COVID-19 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.
“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.”