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Stem Cell Therapy
Mesenchymal Stem Cells for Rectolabial Fistula (RVF Trial)
Phase 1 & 2
Recruiting
Led By Amy Lightner, MD
Research Sponsored by Amy Lightner
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Single-tract, rectovaginal fistula in the setting of Crohn's disease.
Females 18-75 years of age with a diagnosis of Crohn's disease for at least six months duration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6, month 12
Awards & highlights
RVF Trial Summary
This trial is testing whether bone marrow-derived stem cells can help treat rectovaginal fistulas in Crohn's patients.
Eligible Conditions
- Rectolabial Fistula
- Crohn's Disease
- Rectovaginal Fistula
- Crohn Disease
RVF Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowRVF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6, month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6, 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
Complete clinical healing
Lack of response
Partial healing
+1 moreSide effects data
From 2020 Phase 1 trial • 14 Patients • NCT0286672133%
Vomiting
33%
Non-cardiac Chest Pain
33%
Abdominal Pain
33%
Generalized Pain
33%
Change in Appetite
33%
Risk of Pathogen Exposure
33%
Hypomagnesemia
33%
Myalgia
33%
Lethargy
33%
Syncope
33%
Increased Sputum Production
33%
Cough
33%
PICC Line Insertion
33%
Diarrhea
33%
Cystic Fibrosis Pulmonary Exacerbation
33%
Constipation
33%
PICC Line Right Upper Extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
1 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram
3 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram
5 x 10^6 Human Allogeneic Mesenchymal Stem Cells Per Kilogram
RVF Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mesenchymal Stem CellsExperimental Treatment1 Intervention
Direct injection of adult allogeneic bone marrow derived mesenchymal stem cells at a dose of 75 million cells into rectovaginal fistula at baseline with a possible repeat injection at 3 months if not completely healed from the first injection.
Group II: PlaceboPlacebo Group1 Intervention
Direct injection of normal saline with a possible repeat injection at 3 months if not completely healed from the first injection. If not completely healed after 6 months, participants will then cross over to the treatment group to receive a direct injection of adult allogeneic bone marrow derived mesenchymal stem cells at a dose of 75 million cells into rectovaginal fistula.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesenchymal Stem Cells
2016
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
Amy LightnerLead Sponsor
4 Previous Clinical Trials
110 Total Patients Enrolled
Amy Lightner, MD2.33 ReviewsPrincipal Investigator - The Cleveland Clinic
The Cleveland Clinic
18 Previous Clinical Trials
1,584 Total Patients Enrolled
1Patient Review
I strongly advise against letting Dr. Lightener operate on anyone. She destroyed my body and my life.
Frequently Asked Questions
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