SUGAR LAND, Texas--(BUSINESS WIRE)--#arthritis--FDA has authorized Hope Biosciences’ adipose-derived mesenchymal stem cells (HB-adMSCs) for use in the first pediatric clinical trial, to evaluate if intravenous infusion affects signs and symptoms of oligoarticular or polyarticular juvenile idiopathic arthritis (JIA) and improve quality of life in suffering children aged 2 – 16 years old.
Hope Biosciences’ proprietary cell therapy product has been previously employed in multiple conditions similar or related to JIA, including rheumatoid arthritis, chronic musculoskeletal pain, severe osteoarthritis, psoriatic arthritis, and lupus. These protocols concluded that HB-adMSCs are safe and can create significant improvements in pain levels and functionality.
“Our technology has safely treated children as young as 18 months with conditions ranging from congenital muscular dystrophy to cerebral palsy, epilepsy, and autoimmune disorders,” said Donna Chang, CEO of Hope Biosciences. “We are confident that the same technological advancements that have delivered consistent, high-volume, and repeatable cell therapy treatments in adult trials will pave the way for effective treatments in pediatric patients. Encouraging results from our adult rheumatoid arthritis trials, where participants showed significant and lasting improvements in joint pain and function, give us great hope for similar success in children with juvenile arthritis.”
JIA, formerly known as “Juvenile Rheumatoid Arthritis,” is an autoimmune disease of unknown cause. The arthritic condition affects an estimated 300,000 children in the United States and approximately 3 million globally. Characterized by chronic or cyclical joint pain in small and large joints, the disease often manifests with associated fatigue, rash, blurred vision, fever, and appetite changes. Current medical treatment focuses on controlling symptoms.
The Phase II clinical trial (NCT06623240) is run by Hope Biosciences Research Foundation (HBRF) at their site in Sugar Land, Texas and is currently enrolling. The trial is a balanced randomized, double-blind, crossover design dictating an 8-week active treatment period, during which subjects will receive three infusions. Then, twelve weeks will pass without treatment. Finally, three more treatments will be administered over another 8-week period. Approximately half of participants will receive treatment, followed by the 12-week washout period, then placebo; the other half will receive placebo, followed by the 12-week washout period, then treatment. There is no treatment cost; travel to the site, however, are not covered. For more, visit hopebio.org, write HBRF at clinical@hopebio.org or call (346) 900-0340, ext. 101.
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