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NCT04548583 · ClinicalTrials.gov registry record · Phase 1
Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis
A Phase 1 study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT04548583 is a Phase 1 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 7 participants.
The verdict
NCT04548583, a Phase 1 study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Crohn's disease has several phenotypes (inflammatory, stricturing, fistulizing) and location (small bowel, ileocecal, colon, and perianal). Approximately one third of patients have inflammation limited to the colon. Up to two thirds will become medically refractory and require a total abdominal colectomy for symptom control. The purpose of this study is to determine the safety and efficacy of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory Crohn's colitis.
Interventions
- OTHER Placebo
- DRUG Remestemcel-L
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2023-11-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04548583
The ClinicalTrials.gov registry entry for NCT04548583 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04548583 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04548583 about?
NCT04548583 is a clinical study titled "Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis". Crohn's disease has several phenotypes (inflammatory, stricturing, fistulizing) and location (small bowel, ileocecal, colon, and perianal). Approximately one third of patients have inflammation limited to the colon. Up to two thirds will become medically refractory and require a total abdominal cole...
What is the current status of trial NCT04548583?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2020-11-04. Estimated completion is 2023-11-15.
What interventions are being tested in trial NCT04548583?
The interventions under investigation include: Placebo (OTHER), Remestemcel-L (DRUG).
Who is sponsoring clinical trial NCT04548583?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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