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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
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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 3, month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3, month 12
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 moreSide effects data
From 2018 Phase 3 trial • 32 Patients • NCT026521306%
Pneumonia
6%
Septic shock
3%
Pseudomonas infection
3%
Laceration
3%
Cholecystitis
3%
Bronchopulmonary aspergillosis
3%
Enterococcal infection
3%
Nocardiosis
3%
Weight decreased
3%
Hyperglycaemia
3%
Bacteraemia
3%
Pneumonia pneumococcal
3%
Vulval abscess
3%
Osteomyelitis acute
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
1,033 Previous Clinical Trials
1,365,357 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- If you are taking budesonide, you must have been taking the same amount consistently for at least 2 weeks.You have taken antibiotics to treat ulcerative colitis for at least two weeks.Your health condition has not gotten worse, and may have even improved.If you stopped taking oral 5-ASA compounds or oral corticosteroids (including budesonide), you must have stopped taking them at least 2 weeks ago.You were given a fake medication (placebo) during your first injection.You are allowed to have taken certain medications before, but you need to stop taking any monoclonal antibodies for 4 weeks before the trial.
Research Study Groups:
This trial has the following groups:- Group 1: remestemcel-L (150 million cells)
- Group 2: Placebo
- Group 3: remestemcel-L (300 million cells)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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