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Pediatric MSC-AFP Sub-study for Crohn's Fistula

NCT03449069 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-03-13

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of using an autologous mesenchymal stromal cell (MSC) coated fistula plug in people with fistulizing Crohn's disease. Autologous means these cells to coat the plug come from the patient.

Conditions

  • Fistula in Ano
  • Crohn Disease

Interventions

DRUG

MSC-AFP

Patients will have a mesenchymal stromal cell coated anal fistula plug placed in their Crohn's perianal fistula tract.

Sponsors & Collaborators

Principal Investigators

  • Michael C Stephens · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-07-23
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03449069 on ClinicalTrials.gov