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NCT07077746 · ClinicalTrials.gov registry record · Phase 2
HB-adMSCs for the Treatment of Crohn's Disease
A Phase 2 study of Crohn Disease (CD), sponsored by Hope Biosciences Research Foundation.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT07077746: Recruiting Phase 2 study of Crohn Disease (CD), sponsored by Hope Biosciences Research Foundation.
NCT07077746 is a Phase 2 study of Crohn Disease (CD) that is actively recruiting participants, run by Hope Biosciences Research Foundation. The registered enrollment target is 46 participants, below the 84-participant average among 5 other Crohn Disease (CD) trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07077746, a Phase 2 study of Crohn Disease (CD), is actively recruiting participants, sponsored by Hope Biosciences Research Foundation.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study 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
Primary Outcome
Changes from Baseline (Week 0) up to Week 52 in Crohn's Disease Activity Index (CDAI) scores. Specifically, clinical response defined as a reduction of at least 100 points in Crohn's Disease Activity Index (CDAI) from baseline. Score ranges from 0 (minimum) - 450 (maximum), the least being asymptomatic and the greatest being most severe.
Conditions Studied
Interventions
- DRUG HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells
- DRUG 0.9% sodium chloride
Study Locations (1)
Texas
- Hope Biosciences Research Foundation - Sugar Land
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2026-03 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT07077746 shows while recruiting
NCT07077746 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 84-participant average among 5 other Crohn Disease (CD) trials with a reported enrollment target (45% lower).
The record links to 1 condition, with Crohn Disease (CD) appearing as the primary indexed condition, and to 2 interventions - of which HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells is the first listed.
NCT07077746 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT07077746 about?
NCT07077746 is a clinical study titled "HB-adMSCs for the Treatment of Crohn's Disease". 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...
What is the current status of trial NCT07077746?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2026-03. Estimated completion is 2027-12.
What conditions does trial NCT07077746 study?
This clinical trial studies the following conditions: Crohn Disease (CD).
What interventions are being tested in trial NCT07077746?
The interventions under investigation include: HB-adMSCs - Hope Biosciences Adipose Derived Mesenchymal Stem Cells (DRUG), 0.9% sodium chloride (DRUG).
Who is sponsoring clinical trial NCT07077746?
This trial is sponsored by Hope Biosciences Research Foundation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07077746 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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