Hope Biosciences Research Foundation Authorized to Begin Phase II Clinical Trial in Stem Cell Therapy for Juvenile Idiopathic Arthritis

SUGAR LAND, Texas--(BUSINESS WIRE)--Hope Biosciences Research Foundation (HBRF) has received Food and Drug Administration (FDA) Authorization to administer Hope Biosciences’ adipose-derived mesenchymal (adult) stem cells (HB-adMSCs) to pediatric patients aged 2 – 16 years old suffering from juvenile idiopathic arthritis (JIA), the first FDA authorization for work in this cell type in this condition and HBRF’s first pediatric clinical trial.

JIA, formerly known as “Juvenile Rheumatoid Arthritis,” affects an estimated 300,000 children in the U.S. and 3 million globally. Characterized by chronic or cyclical pain in small and large joints, fatigue, and associated organ and other changes, treatment focuses on controlling symptoms, with an economic burden as high as $30,000 per year by popular report.

“Participants in this trial have at least three joints affected, which means their daily life is significantly and measurably impacted by the disease,” elaborates Donna Chang, President, HBRF. “HB-adMSCs have shown promise in Rheumatoid Arthritis in adults, as well as in chronic musculoskeletal pain, osteoarthritis, psoriatic arthritis, and lupus, all conditions with similarities to JIA. These cells have also been safely administered to multiple pediatric patients suffering from other conditions. We are hopeful this trial will affect real improvements in quality of life for these boys and girls, and create hope for the wider JIA community.”

The Phase II clinical trial (NCT06623240) is a balanced randomized, double-blind, crossover study that will enroll 66 participants at HBRF for 72 weeks. During an 8-week active treatment period subjects will receive three infusions of HB-adMSCs at a dose determined by bodyweight. Then, twelve weeks will pass without treatment. Finally, three more treatments will be administered over another 8-week period. Approximately half of the participants will receive treatment, followed by the washout period, then placebo; the other half will receive placebo, then washout period, and treatment. HBRF will pursue peer-reviewed publication of results.

Founded in 2020, in its fourth year of operation HBRF remains the only entity in the world exploring the effects of high volume, sustained application of adult stem cells on diseases and conditions that currently have no cure and affect substantial portions of the American population. To date HBRF has obtained FDA authorization for more than 40 clinical protocols. Learn more at hopebio.org.