MedTrace Logo

Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Crohn's Colitis

NCT04548583 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-04-16

No results posted yet for this 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.

Conditions

  • Crohn Colitis

Interventions

DRUG

Remestemcel-L

adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory Crohn's colitis

DRUG

Remestemcel-L

adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory Crohn's colitis

OTHER

Placebo

Normal saline

Sponsors & Collaborators

  • Mesoblast, Inc.

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Amy Lightner, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-04
Primary Completion
2023-11-15
Completion
2023-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04548583 on ClinicalTrials.gov