NCT04519697TerminatedPhase 1/2
Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease
A Phase IB/IIA Study of Adult Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in the Setting of Crohn's Disease.
Source: ClinicalTrials.gov · Last updated 16 Apr 2026
Reason given: PI left Cleveland Clinic
Brief summary (registry, in English)
Approximately 10% of all female Crohn's patients have a rectovaginal fistula. Rectovaginal fistulas cause air, stool, and/or drainage per vagina and may be associated with pain, recurrent urinary tract infections and diminished quality of life. Conventional therapy includes immunosuppressive medications used to treat Crohn's disease and various surgical interventions. However, all have limited ability to heal these fistulas. The purpose of this study is to determine the safety and efficacy of using allogeneic bone marrow derived mesenchymal stem cells (MSCs) to treat people with rectovaginal fistulas in the setting of Crohn's disease.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 17 Aug 2020
- Start date
- 28 Oct 2020
- Primary completion date
- 15 Nov 2023
- Lead sponsor
- Anthony Lembo
- Diseases
- Crohn's disease
- NCT number
- NCT04519697
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Clinically significant medical conditions within the six months before administration of MSCs: e.g. myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the subject.
- Investigational drug within 30 days of treatment
- Change in Crohn's immunosuppressive regimen within the 2 months prior to enrollment
- Inability to wean corticosteroids
Other illness
- History of cancer including melanoma (with the exception of localized skin cancers) within one year of screening.
- History of colorectal cancer within 5 years.
- Presence of a rectovaginal or perineal body fistula
- Uncontrolled intestinal Crohn's disease which will require escalation for medical therapy or surgery within 2 months of enrollment
- Severe anal canal disease that is stenotic and requires dilation
Lab values
- Specific exclusions:
- Hepatitis B or C
- HIV
- Abnormal AST or ALT at screening(defined as >/= 2x ULN)
Other
- Inability to give informed consent.
- Pregnant or breast feeding or trying to become pregnant.
- Unwilling to agree to use acceptable contraception methods during participation in study
Who the study is looking for
- Females 18-75 years of age with a diagnosis of Crohn's disease for at least six months duration.
- Single-tract, rectovaginal fistula in the setting of Crohn's disease.
- Have no contraindications to MR evaluations: e.g. pacemaker or magnetically active metal fragments, claustrophobia
- Ability to comply with protocol
- Competent and able to provide written informed consent, and ability to comply with protocol
- Concurrent Crohn's related therapies with stable doses (>2 months) corticosteroids, 5-ASA drugs, immunomodulators, anti-TNF therapy, anti-integrin and anti-interleukin are permitted
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.