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Mesenchymal Stem Cells

Remestemcel-L for Ulcerative Colitis (UC Trial)

Phase 1 & 2

Waitlist Available

Led By Amy Lightner

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

UC Trial Summary

This trial will test whether or not using a culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product (MSCs) delivered by targeted endoscopic delivery is safe and effective for treating patients with medically refractory ulcerative colitis.

Eligible Conditions

Ulcerative Colitis

UC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment related adverse events

Secondary outcome measures

Clinical and endoscopic remission

Clinical and endoscopic response

Lack of response

+2 more

Other outcome measures

EuroQol 5 Dimensions survey

IBD-patient reported treatment impact survey

Inflammatory bowel disease questionnaire

+1 more

Side effects data

From 2018 Phase 3 trial • 32 Patients • NCT02652130

Pneumonia

Septic shock

Laceration

Hypoalbuminaemia

Pseudomonas infection

Cholecystitis

Bronchopulmonary aspergillosis

Enterococcal infection

Nocardiosis

Osteomyelitis acute

Weight decreased

Hyperglycaemia

Bacteraemia

Pneumonia pneumococcal

Vulval abscess

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

UC 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

1,030 Previous Clinical Trials

1,363,994 Total Patients Enrolled

4 Trials studying Ulcerative Colitis

363 Patients Enrolled for Ulcerative Colitis

Amy Lightner2.33 ReviewsPrincipal Investigator - Cleveland Clinic Foundation, Cleveland OH

The Cleveland Clinic

1Patient Review

I would not recommend Dr Lightener. My surgery did not go well. I have had to have follow up surgeries and I am still experiencing problems.

Media Library

Remestemcel-L (Mesenchymal Stem Cells) Clinical Trial Eligibility Overview. Trial Name: NCT04543994 — Phase 1 & 2

Ulcerative Colitis Research Study Groups: Remestemcel-L (150 million cells), Remestemcel-L (300 million cells), Placebo

Ulcerative Colitis Clinical Trial 2023: Remestemcel-L Highlights & Side Effects. Trial Name: NCT04543994 — Phase 1 & 2

Remestemcel-L (Mesenchymal Stem Cells) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04543994 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators currently looking for participants for this research project?

"Yes, as of 4/4/2022 this clinical trial is still actively recruiting patients. This particular trial was first posted on 11/10/2020 and seeks to enroll a total of 24 patients from 1 location."

Answered by AI

Could I review the screening process for this clinical trial?

"The ideal candidate for this clinical trial is somebody 18-75 years old, who currently has colitis but has also been treated with corticosteroids, 5-ASA drugs, thiopurines, methotrexate, anti-TNF therapy, anti-integrin or interleukin in the past. If a monoclonal antibody was used as part of prior treatment, there must be a 4 week washout period before enrolling in this study. Additionally, if AZA, 6-MP or MTX have been recently discontinued they must have been stopped for at least 4 weeks. Eligible participants can"

Answered by AI

How many volunteers are taking part in this research?

"Yes, the information available from clinicaltrials.gov indicates that this study is still recruiting participants. The trial was first posted on November 10th, 2020 and was last updated on April 4th, 2022. They are looking for 24 patients at a single location."

Answered by AI

What is the scientific community's consensus on Remestemcel-L?

"There are three clinical trials underway that focus on Remestemcel-L. Unfortunately, none of these active studies are in Phase 3. Most investigations for Remestemcel-L take place in Cleveland, Ohio; however, there are three other centres conducting research on this potential treatment."

Answered by AI