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Study of Mesenchymal Stem Cells for the Treatment of Medically Refractory Ulcerative Colitis (UC)

NCT04543994 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-04-16

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and efficacy of using remestemcel-L, an ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory ulcerative colitis.

This study will enroll adult patients with medically refractory ulcerative colitis who are planning to switch biologic therapy or undergo colectomy as the next stage in their treatment plan.

Conditions

Interventions

DRUG

Remestemcel-L

An ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory ulcerative colitis

DRUG

Remestemcel-L

An ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory ulcerative colitis

OTHER

Placebo

Normal saline

Sponsors & Collaborators

  • Mesoblast, Inc.

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Amy Lightner · Cleveland Clinic Foundation, Cleveland OH

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
2020-11-10
Primary Completion
2023-11-15
Completion
2023-11-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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 NCT04543994 on ClinicalTrials.gov