Hope Biosciences Research Foundation Opens Enrollment for FDA-Authorized Crohn’s Disease Stem Cell Trial

Phase II study to evaluate the potential of HB-adMSCs in reducing inflammation and improving quality of life for adults living with Crohn’s Disease

SUGAR LAND, Texas--(BUSINESS WIRE)--Hope Biosciences Research Foundation (HBRF) today announced the opening of enrollment for a Phase II clinical trial evaluating the potential of intravenously infused allogeneic, adipose-derived mesenchymal stem cells (HB-adMSCs) in adults living with Crohn’s Disease.

The FDA-authorized study (NCT07077746) will enroll 46 participants at HBRF’s clinical research site in Sugar Land, Texas. This randomized, double-blind, placebo-controlled trial will assess whether six infusions of 200 million HB-adMSCs over a 16-week treatment period can improve clinical signs and symptoms of Crohn’s Disease. There is no cost to participants for study-related treatment, though travel expenses are not covered.

Mesenchymal stem cells (MSCs) are known for their ability to regulate immune activity and reduce harmful inflammation. In Crohn’s Disease, the immune system mistakenly attacks the digestive tract, leading to chronic inflammation and tissue damage. MSCs have the unique capacity to regulate overactive immune responses, support tissue repair, and restore balance in the gut environment.

“Crohn’s Disease profoundly impacts patients not only physically, but socially, relationally, and professionally,” says Donna Chang, President, HBRF. “We have consistently observed success in lowering inflammatory markers across a wide range of autoimmune conditions. By addressing the underlying drivers of inflammation rather than just masking symptoms, HB-adMSCs may offer a novel therapeutic approach for Crohn’s patients.”

Crohn’s Disease is a chronic form of inflammatory bowel disease (IBD) that can cause severe abdominal pain, persistent diarrhea, fatigue, malnutrition, and weight loss. The condition often results in significant healthcare costs and long-term disability. According to the Centers for Disease Control and Prevention, more than one million Americans live with Crohn’s Disease, and over three million are affected by IBD more broadly. The annual economic burden of Crohn’s Disease in the U.S. is estimated at $3 billion, with individual household costs exceeding $30,000 annually.

About Hope Biosciences Research Foundation

Hope Biosciences Research Foundation (HBRF) is a 501(c)(3) non-profit organization based in Sugar Land, Texas, conducting FDA-authorized clinical trials in regenerative medicine. HBRF’s mission is to accelerate the discovery and accessibility of stem cell therapies that can improve lives across a broad spectrum of diseases.