The clinical study is aimed at evaluating efficacy and safety of Hope’s autologous, adipose-derived mesenchymal stem cells (HB-adMSCs)
Hope Biosciences to start FDA approved Stem Cell clinical trial to fight against COVID-19. (Credit: Gerd Altmann from Pixabay.)
Clinical stage biotechnology firm Hope Biosciences has secured the US Food and Drug Authority (FDA) approval for a Phase 2 clinical trial of stem cells to provide immune support against COVID-19.
The Phase 2 clinical study is aimed at evaluating efficacy and safety of the company’s autologous, adipose-derived mesenchymal stem cells (HB-adMSCs).
Hope Biosciences president and CEO Donna Chang said: “This study will utilise our proprietary core technology to deliver high quality, pure mesenchymal stem cells with standardized doses and multiple treatments.
“Our novel technology allows us to overcome the burdens of traditional cell therapy, such as inability to make enough cells to make a significant impact. We can produce, on-demand, over 1,000 highly concentrated HB-adMSC treatments from a single tablespoon of the patient’s own fat tissue.”
Hope will administer HB-adMSCs through five intravenous infusions
According to the company, inflammation is a driving force behind disease progression, and it is critical to regulating the immune system in COVID-19 patients. MSCs are said to have immunomodulatory and regenerative potential.
Hope’s Phase 2 trial is a single-arm, non-randomised study designed to enrol 75 participants, either aged 50 years and having preexisting health conditions or are at high-exposure risk.
The primary objective of the study is to determine the efficacy of HB-adMSCs to prepare the immune system, enabling it to fight the virus, and the pretreatment is anticipated to prevent the progression of COVID-19.
In the study, HB-adMSCs are administered through five intravenous infusions over fourteen weeks and follow-up evaluations through 6 months.
Also, the participants will be monitored for changes in health status, including immune cell levels, inflammatory markers, and requirements for supplemental care or hospitalisation.
Chang added: “Most people who have been severely affected by COVID-19 had preexisting conditions. We are pretreating participants who are at higher risk of developing severe COVID-19, with the belief that we can prepare their immune systems, giving them their best chance to fight the virus.
“Our ultimate goal is to prevent anyone from needing mechanical ventilation. We believe that interceding early in the inflammatory process will give us the best possible outcome.
“Treating the disease is very important but if we have a chance to prevent the condition, we must explore all options. We appreciate the FDA’s willingness to take this groundbreaking approach at such a critical time for our nation.”