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Mesenchymal Stem Cells

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

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 3, month 12

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

Pneumonia

Septic shock

Cholecystitis

Bacteraemia

Bronchopulmonary aspergillosis

Enterococcal infection

Nocardiosis

Osteomyelitis acute

Pneumonia pneumococcal

Pseudomonas infection

Vulval abscess

Laceration

Weight decreased

Hyperglycaemia

Hypoalbuminaemia

Febrile neutropenia

Thrombocytopenia

Pneumatosis intestinalis

Haematochezia

Oedema peripheral

Hyponatraemia

Osteonecrosis

Acute lymphocytic leukaemia recurrent

Post transplant lymphoproliferative disorder

Eczema

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

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

1,057 Previous Clinical Trials

1,371,448 Total Patients Enrolled

Amy Lightner, MD2.33 ReviewsPrincipal Investigator - The Cleveland Clinic

The Cleveland Clinic

18 Previous Clinical Trials

1,459 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!