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Mesenchymal Stem Cells

Remestemcel-L for Granulomatous Colitis

Phase 1 & 2
Waitlist Available
Led By Amy Lightner, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3, month 12
Awards & highlights

Summary

This trial is testing whether bone marrow-derived stem cells can help treat Crohn's colitis when other medical treatments have failed.

Eligible Conditions
  • Granulomatous Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3, month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3, month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Treatment related adverse events
Secondary study objectives
Clinical response
Complete clinical healing
Crohn's disease activity index
+6 more

Side effects data

From 2018 Phase 3 trial • 32 Patients • NCT02652130
6%
Pneumonia
6%
Septic shock
3%
Cholecystitis
3%
Bacteraemia
3%
Bronchopulmonary aspergillosis
3%
Enterococcal infection
3%
Nocardiosis
3%
Osteomyelitis acute
3%
Pneumonia pneumococcal
3%
Pseudomonas infection
3%
Vulval abscess
3%
Laceration
3%
Weight decreased
3%
Hyperglycaemia
3%
Hypoalbuminaemia
3%
Febrile neutropenia
3%
Thrombocytopenia
3%
Pneumatosis intestinalis
3%
Haematochezia
3%
Oedema peripheral
3%
Hyponatraemia
3%
Osteonecrosis
3%
Acute lymphocytic leukaemia recurrent
3%
Post transplant lymphoproliferative disorder
3%
Eczema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Remestemcel-L

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: remestemcel-L (300 million cells)Experimental Treatment1 Intervention
Targeted endoscopic delivery of remestemcel-L, at a dose of 300 million cells into the submucosal layer of the colon wall at baseline. If at 3 months post injection of remestemcel-L there is clinical, endoscopic or radiographic improvement, patients will receive a second dose of remestemcel-L at a dose of 300 million MSCs (same dose at initial).
Group II: remestemcel-L (150 million cells)Experimental Treatment1 Intervention
Targeted endoscopic delivery of remestemcel-L, at a dose of 150 million cells into the submucosal layer of the colon wall at baseline If at 3 months post injection of remestemcel-L there is clinical, endoscopic or radiographic improvement, patients will receive a second dose of remestemcel-L at a dose of 150 million MSCs (same dose at initial)
Group III: PlaceboPlacebo Group1 Intervention
Direct injection of normal saline into the submucosal layer of the colon wall. If not completely healed after 3 months, participants will then cross over to the treatment group to receive a direct injection of remestemcel-L, at a dose of 150 or 300 million cells into the submucosal layer of the colon wall. If at 6 months post injection of remestemcel-L there is clinical, endoscopic or radiographic improvement, patients will receive a second dose of remestemcel-L at a dose of 150 or 300 million MSCs (same dose at initial).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remestemcel-L
2015
Completed Phase 3
~40

Find a Location

Who is running the clinical trial?

Mesoblast, Inc.Industry Sponsor
21 Previous Clinical Trials
2,417 Total Patients Enrolled
The Cleveland ClinicLead Sponsor
1,045 Previous Clinical Trials
1,370,651 Total Patients Enrolled
Amy Lightner, MD2.33 ReviewsPrincipal Investigator - The Cleveland Clinic
The Cleveland Clinic
18 Previous Clinical Trials
1,519 Total Patients Enrolled
5Patient Review
Dr. Lightner demonstrated exceptional skill and knowledge in removing my husband's second jpouch. He had been diagnosed with Crohns of the jpouch, and now has a permanent ileostomy. We understand that only about 15% of patients with a jpouch will have that pouch fail. His original pouch was done in MT, and after twenty years, that redo failed. Dr. Lightner took her time excising the pouch, as it was filled with strictures and extreme Crohns. We are beyond grateful for her expertise!

Media Library

Remestemcel-L (Mesenchymal Stem Cells) Clinical Trial Eligibility Overview. Trial Name: NCT04548583 — Phase 1 & 2
Granulomatous Colitis Research Study Groups: remestemcel-L (150 million cells), Placebo, remestemcel-L (300 million cells)
Granulomatous Colitis Clinical Trial 2023: Remestemcel-L Highlights & Side Effects. Trial Name: NCT04548583 — Phase 1 & 2
Remestemcel-L (Mesenchymal Stem Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04548583 — Phase 1 & 2
~5 spots leftby Sep 2025
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