Hope Biosciences Receives FDA Approval to Commence Stem Cell Clinical Trial for Protection Against COVID-19
Hope Biosciences, indicated that the FDA approved a Phase II clinical study to evaluate the safety and efficacy of their stem cell product. It is an autologous, adipose-derived mesenchymal stem cell (HB-adMSC) to provide immune support against COVID-19. There is scientific evidence to demonstrate that mesenchymal stem cells (MSC’s) have both immunomodulatory and regenerative potential.
Moreover, clinical trial results from a recent study showed that HB-adMSC’s were safe and effective in patients with Rheumatoid Arthritis. In COVID-19 patients, Inflammation is a key factor regarding disease progression, and it is crucial to sway the immune system as early as possible.
Autologous Stem Cells ?
“This study will utilize 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. 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,” said Donna Chang, President and CEO of Hope Biosciences.
Phase II Clinical Trial
This is a single arm, non-randomized Phase II trial that will enroll 75 patients that might have greater risk with Covid-19 than the average person. The study will aim to evaluate the efficacy of HB-adMSC’s to prepare the immune system so that it is better able to fight the virus.
In addition, they expect that this pretreatment will activate the immune system in a way for it to better handle Covid-19. Hence, the therapy might protect patients so that they do not need to enter the hospital or ICU units.
Treatment Delivery
Researchers deliver HB-adMSC’s via five intravenous infusions over 14 weeks and follow-up sessions for 6 months. The clinical team will check the health of these study participants by recording their immune cells, inflammatory markers, and any need for critical care.
More Clinical Trials
Indeed, Hope Biosciences filed 3 new drug applications with respect to Covid-19. This initial study includes patients who have banked their stem cells with Hope Biosciences. The next 2 trials will be allogenic, rather than autologous, which means they will use stem cells donated from live, healthy individuals. The objective will be protecting patients of high risk against Covid.19.
A New Hope
“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,” said Donna Chang.