Hope Biosciences has been given clearance from the US Food and Drug Administration (FDA) to move ahead with a phase 2 trial to evaluate its investigational stem cell therapy in providing immune support against COVID-19.
In this regard, Hope Biosciences will be evaluating the safety and efficacy of its adipose-derived mesenchymal stem cells (HB-adMSCs) in the mid-stage clinical trial.
The phase 2 trial, which will be a randomised, placebo-controlled, double-blind, single center study, is likely to feature 100 frontline healthcare workers and first responders. Its primary goal will be to determine the efficacy of HB-adMSCs in giving immune support against COVID-19.
Hope Biosciences plans to randomly sort participants into one of four groups, which include 50 million cells/dose, 100 million cells/dose, 200 million cells/dose or placebo.
HB-adMSCs or placebo will be intravenously administered for a total of five infusions through a 14-week period with assessments to be carried out before each infusion and at 26 weeks to end the study, said the company.
The clinical stage biotechnology company claims that based on demand, its core technology can generate high-quality, fully characterised, fresh mesenchymal stem cells.
According to the company, mesenchymal stem cells are regarded for their immunomodulatory and regenerative potential. The company further said that in a recently held phase I/II clinical trial for rheumatoid arthritis, results indicated to show that HB-adMSCs were safe and effective in lessening systemic inflammation.
Hope Biosciences president and CEO Donna Chang said: “It is our expectation that providing HB-adMSC therapy will boost the immune system, especially in cases of individuals at high-risk of developing COVID-19.
“A healthy immune system is better able to defend against infectious agents like SARS-CoV-2 and decreases the chance a patient will become critically ill. This not only helps keep people healthy, but it decreases the tremendous burden already on a stressed healthcare system.
“With this treatment, we hope to build a line of defense for our most vulnerable.”
In April 2020, the company received approval from the FDA to carry out a single-arm non-randomised phase 2 trial to evaluate the ability of HB-adMSCs in providing immunity against COVID-19. The company said that it will execute the two mid-stage trials parallelly.