Hope Biosciences Begins Phase II Trial for Stem Cell Therapy in Juvenile Arthritis

Hope Biosciences Research Foundation (HBRF), based in Sugar Land, Texas, has achieved a significant milestone by gaining authorization from the Food and Drug Administration (FDA) to use its adipose-derived mesenchymal stem cells (HB-adMSCs) in treating children aged 2 to 16 years who suffer from juvenile idiopathic arthritis (JIA). This authorization marks the first time the FDA has approved this type of cell therapy for this condition, and it is also HBRF's inaugural pediatric clinical trial.

Juvenile idiopathic arthritis, once termed "Juvenile Rheumatoid Arthritis," is a prevalent condition impacting roughly 300,000 children in the United States and 3 million worldwide. This ailment is known for causing persistent or recurrent pain in both small and large joints, leading to fatigue and other associated health issues. Current treatments primarily aim to manage symptoms, with reports indicating that this can impose a financial burden of up to $30,000 annually.

Donna Chang, President of HBRF, highlighted the significant impact of JIA on daily life, especially when multiple joints are affected. She noted that HB-adMSCs have previously shown promise in treating Rheumatoid Arthritis in adults, as well as in conditions like chronic musculoskeletal pain, osteoarthritis, psoriatic arthritis, and lupus, which share similarities with JIA. These stem cells have also been safely used in pediatric patients with other ailments. Chang expressed optimism that the trial may lead to meaningful improvements in the quality of life for young patients and provide hope to the broader JIA community.

The Phase II clinical trial, registered under NCT06623240, is designed as a balanced randomized, double-blind, crossover study. It will involve 66 participants over a span of 72 weeks, hosted at HBRF. Participants will undergo an 8-week active treatment phase, receiving three infusions of HB-adMSCs at doses adjusted for their body weight. This will be followed by a 12-week period without any treatment. Subsequently, participants will receive three additional treatments over another 8-week period. The study design includes a comparison between groups, with half of the participants receiving the stem cell treatment first, followed by a washout phase and then a placebo, while the other half will receive the treatments in the reverse order. HBRF plans to publish the findings in a peer-reviewed journal.

Established in 2020, HBRF is in its fourth year of operation and distinguishes itself as the sole organization globally that investigates the impact of high-volume, sustained adult stem cell applications on incurable diseases and conditions affecting a significant portion of the American population. To date, HBRF has successfully secured FDA approval for over 40 clinical protocols.