MedTrace Logo

AlloGeneic Human Mesenchymal Stem Cells (hMSC) in PAtients With FistuLizing Crohn's Disease Via PErifistula iNjEctions (GALENE)

NCT02677350 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2026-01-27

No results posted yet for this study

Summary

To evaluate the role of allogeneic mesenchymal stem cells for treatment of perianal fistulizing Crohn disease.

Twenty (20) Crohn's disease patients with complex or multiple perianal or rectovaginal fistulas will be included and will be scheduled to undergo peri-fistula injections after meeting all inclusion/exclusion criteria's at baseline.

Following the Pilot Phase of four (4) subjects, sixteen (16) subjects are scheduled to undergo perianal injections and after meeting all inclusion/exclusion criteria's, will be evaluated at baseline.

Conditions

Interventions

DRUG

Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs)

Peri-fistula injections

Sponsors & Collaborators

  • Joshua M Hare

    lead OTHER

Principal Investigators

  • David Kerman, MD · ISCI / University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2025-12-31
Completion
2026-12-31
FDA Drug
Yes

More Related Trials

Entities

Diseases

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 NCT02677350 on ClinicalTrials.gov