Mesenchymal Stem Cells for the Treatment of Pouch Fistulas in Crohn's
NCT04073472 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL
Last updated 2026-04-15
Summary
The purpose of this study is to determine the safety and feasibility of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with an ileal pouch anal anastomosis (IPAA) who develop a fistula in the setting of Crohn's disease of the pouch.
Conditions
- Crohn's Disease
- Fistula
- Anal Fistula
- Pouch, Ileal
- Pouches, Ileoanal
Interventions
- DRUG
-
mesenchymal stem cells (MSCs)
Allogeneic bone marrow derived mesenchymal stem cells (MSCs) direct injection to an ileal pouch fistula in the setting of Crohn's disease of the pouch
Sponsors & Collaborators
-
The Cleveland Clinic
lead OTHER
Principal Investigators
-
Amy Lightner, MD · The Cleveland Clinic
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-01
- Primary Completion
- 2022-06-01
- Completion
- 2023-06-01
- FDA Drug
- Yes
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