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Mesenchymal Stem Cells
Remestemcel-L for 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
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
- 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
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 and endoscopic remission
Clinical and endoscopic response
Lack of response
+2 moreOther study objectives
EuroQol 5 Dimensions survey
IBD-patient reported treatment impact survey
Inflammatory bowel disease questionnaire
+1 moreSide effects data
From 2018 Phase 3 trial • 32 Patients • NCT026521306%
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
1 Trials studying Colitis
24 Patients Enrolled for Colitis
The Cleveland ClinicLead Sponsor
1,049 Previous Clinical Trials
1,370,731 Total Patients Enrolled
3 Trials studying Colitis
77 Patients Enrolled for 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.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your health condition has either stayed the same or gotten better, not worse.If you are taking budesonide, you must have been taking the same dose for at least 2 weeks.If you were taking 5-ASA or corticosteroid medicine by mouth, you must have stopped taking it for at least 2 weeks before joining the trial.You were given a fake treatment (placebo) during your first injection.You can have taken certain medications in the past, but you need to stop taking any monoclonal antibody medication for 4 weeks before the study.
Research Study Groups:
This trial has the following groups:- Group 1: Remestemcel-L (150 million cells)
- Group 2: Remestemcel-L (300 million cells)
- Group 3: Placebo
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.
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