RecruitingPhase 2NCT07077746

HB-adMSCs for the Treatment of Crohn's Disease

A Randomized, Double-Blind, Phase 2, Efficacy and Safety Study of Allogeneic HB-adMSCs vs Placebo for the Treatment of Crohn's Disease

Sponsor

Hope Biosciences Research Foundation

Enrollment

46 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Crohn Disease (CD)

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

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new stem cell therapy using HB-adMSCs (fat-derived mesenchymal stem cells) to see if it is safe and helps reduce inflammation and symptoms in people with Crohn's disease. **You may be eligible if...** - You are between 18 and 65 years old - You have had a confirmed diagnosis of Crohn's disease for at least 6 months, supported by symptoms, imaging (CT or MRI), or biopsy findings in your medical records **You may NOT be eligible if...** - You have had Crohn's disease for less than 6 months - You do not have documented evidence of your diagnosis in your medical records from the past 3 years - You have conditions that would make stem cell therapy unsafe - You are under 18 or over 65 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells

Allogeneic HB-adMSCs (Hope Biosciences adipose derived mesenchymal stem cells). Dose: 200 million cells (+/- 20%) suspended in 20mL 0.9% sodium chloride. Route: Intravenous. Regimen: Weeks 0, 2, 4, 8, 12, and 16. Preparation: HB-adMSCs syringe should be diluted in 250 mL 0.9% sodium chloride (for a total volume of 270 mL).

DRUG0.9% sodium chloride

0.9% sodium chloride Dose: N/A - 20mL 0.9% sodium chloride. Route: Intravenous. Regimen: Weeks 0, 2, 4, 8, 12, and 16. Preparation: Placebo syringe should be diluted in 250 mL 0.9% sodium chloride (for a total volume of 270 mL).

Locations(1)

Hope Biosciences Research Foundation

Sugar Land, Texas, United States

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NCT07077746

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