← Back to Search

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 below

RVF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6, month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6, 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
Complete clinical healing
Lack of response
Partial healing
+1 more

Side effects data

From 2020 Phase 1 trial • 14 Patients • NCT02866721
33%
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

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
~9 spots leftby Mar 2025