A Phase 2a Study Evaluating DB-3Q Bone Marrow Stem Cell Therapy for Adults With Perianal Fistulizing Crohns Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of increasing doses of DB-3Q, a biological treatment derived from bone marrow mesenchymal stem cells, for adults with Perianal Fistulizing Crohns Disease. This is a phase 2a, double-blind, randomized, placebo-controlled clinical trial sponsored by Direct Biologics, LLC, aiming to better understand treatment impact on this challenging condition. Participants will receive a single dose of DB-3Q or placebo, administered either as a 15 mL or 30 mL direct injection, or a combination of 15 mL intravenous and 30 mL direct injection. The study uses a sequential cohort design with escalating doses to assess different treatment levels. Placebo groups receive matching saline injections. The trial includes several groups to compare these dosing approaches under tightly controlled conditions. During the study, participants undergo screening including pelvic MRI reviewed by a central radiologist to confirm fistula characteristics. Researchers assess combined remission rates at 12 and 24 weeks to measure treatment response. Safety and efficacy are closely monitored throughout the trial, with follow-up visits and evaluations planned to track participant progress over time. The study runs until the end of 2027 and involves adults aged 18 to 75 with active fistulas despite prior therapies.

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease