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Study of Mesenchymal Stem Cells for Pediatric Perianal Fistulizing Crohn's Disease

NCT04791878 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-04-16

No results posted yet for this study

Summary

This study plans to enroll 10 patients aged 13-17 years of age with refractory perianal fistulizing disease. Patients will be treated by direct injection to the fistula tract(s) with 75 million allogeneic bone marrow derived mesenchymal stem cells at baseline and again after 3 months if not completely healed.

Conditions

  • Perianal Fistula Due to Crohn's Disease (Disorder)

Interventions

DRUG

Mesenchymal stem cells

Direct injection of 75 million allogeneic bone marrow derived mesenchymal stem cells at baseline and again after 3 months if not completely healed

Sponsors & Collaborators

  • Anthony Lembo

    lead OTHER

Principal Investigators

  • Amy Lightner, MD · The Cleveland Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2023-11-01
Completion
2023-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04791878 on ClinicalTrials.gov