15 April 2020 - - The US FDA has approved a Phase II clinical trial evaluating the safety and efficacy of US-based biotechnology company Hope Biosciences' allogeneic, adipose-derived mesenchymal stem cells (HB-adMSCs) to provide immune support against COVID-19, the company said.

During this pandemic, there are currently no approved therapies available to support immunity against the Coronavirus disease. 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. In a recent Phase I/II clinical trial for Rheumatoid Arthritis, results appeared to show that HB-adMSCs were safe and effective in attenuating systemic inflammation.

This Phase II study is a randomized, placebo-controlled, double-blind, single center study that is expected to enroll 100 frontline healthcare workers and first responders.

The study's primary objective is to determine the efficacy of HB-adMSCs to provide immune support against COVID-19. Participants will be randomly sorted into one of four groups, placebo, 50 m cells/dose, 100 m cells/dose, or 200 m cells/dose.

HB-adMSCs or placebo will be administered intravenously for a total of 5 infusions over a 14-week period. Assessments will be performed prior to each infusion and at 26 weeks to end the study.

This is the second of three New Drug Applications, related to COVID-19, that Hope Biosciences has filed with FDA.

Hope Biosciences is a clinical stage biotechnology company focused on developing novel cell-based therapeutics for acute and chronic injury and disease.