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Stem Cell Therapy
Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease (RVF Trial)
Phase 1 & 2
Waitlist Available
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6, month 12
Summary
This trial is testing a new treatment using special cells from donor bone marrow to heal rectovaginal fistulas in women with Crohn's disease. These cells are injected directly into the affected area to help repair the tissue. The study aims to see if this method is safe and effective, especially for those who haven't had success with other treatments.
Eligible Conditions
- Vulvar Crohn's disease
- Crohn's Disease
- Rectovaginal Fistula
- Anal fistula
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
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
Complete clinical healing
Lack of response
Partial healing
+1 moreSide effects data
From 2021 Phase 1 & 2 trial • 10 Patients • NCT0335682110%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mesenchymal Stem Cells
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
~240
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
1,443 Total Patients Enrolled
1Patient Review
I strongly advise against letting Dr. Lightener operate on anyone. She destroyed my body and my life.