← Back to Search

Mesenchymal Stem Cells

Remestemcel-L for Granulomatous Colitis

Phase 1 & 2
Recruiting
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
Rectal corticosteroids (ie, corticosteroids [including budesonide] administered to the rectum or sigmoid colon via foam or enema or suppository) for at least 2 weeks.
Parenteral corticosteroids for at least 2 weeks.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3, month 12
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
If you are taking budesonide, you must have been taking the same amount consistently for at least 2 weeks.
Select...
You have taken antibiotics to treat ulcerative colitis for at least two weeks.
Select...
Your health condition has not gotten worse, and may have even improved.
Select...
If you stopped taking oral 5-ASA compounds or oral corticosteroids (including budesonide), you must have stopped taking them at least 2 weeks ago.
Select...
You were given a fake medication (placebo) during your first injection.
Select...
You are allowed to have taken certain medications before, but you need to stop taking any monoclonal antibodies for 4 weeks before the trial.

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

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 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%
Hyperglycaemia
3%
Nocardiosis
3%
Cholecystitis
3%
Laceration
3%
Hypoalbuminaemia
3%
Pseudomonas infection
3%
Bacteraemia
3%
Weight decreased
3%
Bronchopulmonary aspergillosis
3%
Osteomyelitis acute
3%
Pneumonia pneumococcal
3%
Enterococcal infection
3%
Vulval abscess
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?

The Cleveland ClinicLead Sponsor
1,019 Previous Clinical Trials
1,365,051 Total Patients Enrolled
Mesoblast, Inc.Industry Sponsor
21 Previous Clinical Trials
2,417 Total Patients Enrolled
Amy Lightner, MD2.33 ReviewsPrincipal Investigator - The Cleveland Clinic
The Cleveland Clinic
18 Previous Clinical Trials
1,600 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

Frequently Asked Questions

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

Can you provide a synopsis of the research surveying Remestemcel-L's effects?

"Currently, three clinical trials are underway for Remestemcel-L. None of them have entered Phase 3 yet. The primary study location is in Cleveland Ohio; however, other places around the country are also enrolling participants."

Answered by AI

Who is appropriate for inclusion in this trial?

"The requirements to be part of this clinical trial include a diagnosis of granulomatous colitis and being between the ages of 18 and 75. As such, 24 individuals are currently being sought out for enrolment."

Answered by AI

Are there any remaining available slots for participation in this clinical investigation?

"This clinical trial is accepting participants, as evidenced by its listing on clinicaltrials.gov; the initial post was made on November 4th 2020 and has been updated most recently on April 4th 2022."

Answered by AI

Does this investigation offer participation to those above the age of seventy-five?

"This trial is open to individuals aged 18-75. For those below the age of majority, there are 98 studies available and 347 for senior citizens above 65 years old."

Answered by AI

How many participants are eligible for enrollment in this experiment?

"Affirmative. Per clinicaltrials.gov, this medical trial has been recruiting since November 4th 2020 and is currently still enrolling patients. 24 participants need to be sourced from a single facility."

Answered by AI
~6 spots leftby Mar 2025