drugset / Trial / NCT07077746

HB-adMSCs for the Treatment of Crohn's Disease

NCT07077746 ↗

Phase 2 Recruiting 46 enrolled Hope Biosciences Research Foundation
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Methodology: Randomized, double-blind, efficacy and safety study of allogeneic HB-adMSCs vs placebo for the treatment of Crohn's Disease with a 16-week treatment period and a safety and efficacy follow up period for 52 weeks post first treatment. Treatment Duration: 16 weeks General Objectives: To assess the efficacy and safety of multiple intravenous infusions of allogeneic HB-adMSCs by improving signs and symptoms of Crohn's Disease in this subject population. Number of Subjects: 46 (23 in each treatment arm) Indication: Crohn's Disease

Timeline

Start
2026-07
Primary completion
2027-12
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject HB-adMSCs Cell therapy 200 cells Intravenous

Indications