Hope Bio Gets FDA Nod to Start First Stem Cell COVID-19 Clinical Trial – Contract Pharma

Hope Biosciences, a clinical stage biotech focused on developing cell-based therapeutics for acute and chronic disease, said FDA has approved a Phase II clinical trial evaluating efficacy and safety of Hope Biosciences’ autologous, adipose-derived mesenchymal stem cells (HB-adMSCs) to provide immune support against COVID-19. 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. In COVID-19 patients, inflammation is a driving force behind disease progression, and it is critical to regulate the immune system as early as possible.
 
“This study will utilize our proprietary core technology to deliver high quality, pure mesenchymal stem cells with standardized doses and multiple treatments,” said Donna Chang, president and chief executive officer, Hope Biosciences. “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.”
 
This Phase II study is a single arm, non-randomized study that is expected to enroll 75 participants that are either 50 years of age, have preexisting health
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