SUGAR LAND, Texas--(BUSINESS WIRE)--Hope Biosciences’ adipose-derived mesenchymal stem cells are effective in improving joint function in patients actively suffering from Rheumatoid Arthritis (RA), finds a FDA-authorized Phase I/IIa pilot trial.
Fifteen patients received a single intravenous infusion of 200 million adipose-derived mesenchymal stem cells cultured by Hope Biosciences, also known as “HB-adMSCs.” Follow-ups occurred at 4, 12, 26, and 52 weeks, examining efficacy through use of the American College of Rheumatology’s criteria for swollen and tender joint counts, as well as inflammatory markers and laboratory values. Administration of HB-adMSCs resulted in a favorable safety profile, significant and persistent improvements in joint functions, and modest improvements in inflammatory marker C-reactive protein (CRP).
“A small, open label pilot study was necessary not only to measure safety but also to gauge whether cell therapy could be effective in people who have been sick and suffering for a long time,” explains CEO Donna Chang. “We also wanted to demonstrate that our investigational drug can produce consistent results in patients with diverse medical backgrounds. The industry has historically faced challenges with autologous therapies - that is, using a patient’s own stem cells - causing variable results. Our patented technology, however, delivers a high volume of pure, fresh, undifferentiated mesenchymal stem cells, and results from studies like this one show that consistent manufacturing can yield consistent patient results. The effect size is unprecedented, and we believe a strong testament to the consistency and quality of our product.”
RA is a chronic, inflammatory autoimmune disease characterized by joint pain and progressive disability and joint dysfunction affecting approximately 1.5 million Americans and 1% of the population worldwide. There is no cure, and available therapies can have serious side effects. Participants in the Hope Biosciences-sponsored trial suffered an average duration of 11 years at the time of enrollment, experiencing active RA symptoms despite medications.
“Ultimately, the purpose of this study is to inform,” continues Chang. “The results of this pilot study show us that investment in larger trials is warranted, and that endpoints can be consistently achievable. We hope the proof of concept opens the door to hope for patients, and that those suffering from RA and other autoimmune conditions are as encouraged by the results as we are.”
Hope Biosciences is currently in planning stages for a Phase IIb/IIIa randomized, placebo-controlled trial in RA. Mesenchymal stem cells are multipotent progenitor cells that can differentiate into a variety of tissues, including cartilage, muscle, tendon, and bone. Their ability to modulate immune responses and promote regeneration contribute to the therapeutic impact observed in numerous preclinical inflammatory studies.
Hope Biosciences, headquartered in Sugar Land, Texas, is a biopharmaceutical company developing adult stem cell therapeutics for a variety of clinical indications, and the only clinical grade adult stem cell banking facility in the nation that banks both adults and newborns. Stem cells cultured at Hope Biosciences, LLC are currently studied in dozens of FDA-authorized studies for more than 20 disease and injury conditions.
Read the full study through Stem Cell Research & Therapy at https://stemcellres.biomedcentral.com/articles/10.1186/s13287-022-02763-w#MOESM1.
