Hope Biosciences Research Foundation (HBRF) has begun accepting participants for a Phase II clinical trial evaluating the use of intravenously delivered allogeneic, adipose-derived mesenchymal stem cells (HB-adMSCs) in adults with Crohn’s Disease. This FDA-approved study (NCT07077746) will be conducted at HBRF’s clinical research site in Sugar Land, Texas. A total of 46 individuals will be enrolled to receive six infusions of 200 million HB-adMSCs over a 16-week treatment period. There is no cost for study-related care, although travel expenses will not be covered.

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Mesenchymal stem cells are known for their ability to regulate immune responses and reduce inflammation. In Crohn’s Disease, the immune system mistakenly attacks the digestive tract, resulting in chronic inflammation and tissue damage. The HB-adMSCs used in this study are designed to calm these immune responses, support the repair of affected tissues, and help rebalance the gut environment. This makes stem cell therapy a promising potential treatment for Crohn’s patients.

“Crohn’s Disease affects people in many ways, not just physically,” said Donna Chang, President of HBRF. “We have seen success in reducing inflammatory markers in various autoimmune conditions. By targeting the causes of inflammation instead of just treating symptoms, HB-adMSCs could provide a new treatment option for Crohn’s patients.”

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Crohn’s Disease is a chronic inflammatory bowel condition that can cause severe abdominal pain, fatigue, diarrhea, weight loss, and malnutrition. It can significantly impact daily life and often results in high medical costs and long-term complications. According to the Centers for Disease Control and Prevention, over one million Americans are currently living with Crohn’s Disease, while more than three million are affected by inflammatory bowel disease overall. The annual financial burden of Crohn’s in the U.S. is estimated at $3 billion, with some households spending more than $30,000 each year on related healthcare.

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