Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease (RVF)
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.
Sponsor: Anthony Lembo
Terminated
PI left Cleveland Clinic
Other terminated trials from Anthony Lembo
- Fistula · Nov 2024
- Crohn Disease · Nov 2023
- Perianal Fistula Due to Crohn's Disease (Disorder) · Nov 2023
- Crohn Disease · Nov 2022
More terminations from Anthony Lembo
Other Crohn Disease trials with similar outcome
Listed as NCT04519697, this observational or N/A phase trial focuses on Crohn Disease and Crohn Disease of Vulva and remains terminated or withdrawn. Sponsored by Anthony Lembo, it has been updated 11 times since 2020, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)This study is designed to determine the safety and efficacy of direct injection of adult allogeneic bone marrow derived mesenchymal stem cells for the treatment of rectovaginal fistulas in the setting of Crohn's disease. The study will randomize 20 participants. Enrolled participants will be randomized to treatment group with MSCs versus placebo in a 3:1 fashion. Participants in the treatment group will have a direct injection of MSCs at a dose of 75 million cells. This will be given as a direct injection in and around the fistula tract. Participants will be evaluated for complete healing at three months. If complete healing has been achieved patients will continue to be followed for one year. If complete healing has not been achieved at three months, participants will be eligible for a second injection of MSCs at the same dose of 75 million cells. Control participants without complete healing from placebo will cross over at the six month visit to receive an injection of MSCs, and will be followed for one year after treatment for a total duration of 18 months.
This study is designed to determine the safety and efficacy of direct injection of adult allogeneic bone marrow derived mesenchymal stem cells for the treatment of rectovaginal fistulas in the setting of Crohn's disease. The study will randomize 20 participants. Enrolled participants will be randomized to treatment group with MSCs versus placebo in a 3:1 fashion. Participants in the treatment group will have a direct injection of MSCs at a dose of 75 million cells. This will be given as a direct injection in and around the fistula tract. Participants will be evaluated for complete healing at three months. If complete healing has been achieved patients will continue to be followed for one year. If complete healing has not been achieved at three months, participants will be eligible for a second injection of MSCs at the same dose of 75 million cells. Control participants without complete healing from placebo will cross over at the six month visit to receive an injection of MSCs, and will be followed for one year after treatment for a total duration of 18 months.
Status Flow
Change History
11 versions recorded-
Apr 17, 2026 — Present [daily]
Terminated
Status: Unknown → Terminated · Phase: PHASE1/PHASE2 → None
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Sep 2024 — Apr 2026 [monthly]
Unknown PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Unknown PHASE1/PHASE2
Status: Unknown Status → Unknown · Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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May 2024 — Jul 2024 [monthly]
Unknown Status PHASE1_PHASE2
Status: Recruiting → Unknown Status
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May 2022 — May 2024 [monthly]
Recruiting PHASE1_PHASE2
▶ Show 6 earlier versions
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Jan 2022 — May 2022 [monthly]
Recruiting PHASE1_PHASE2
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Apr 2021 — Jan 2022 [monthly]
Recruiting PHASE1_PHASE2
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Jan 2021 — Apr 2021 [monthly]
Recruiting PHASE1_PHASE2
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Dec 2020 — Jan 2021 [monthly]
Recruiting PHASE1_PHASE2
Status: Not Yet Recruiting → Recruiting
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Oct 2020 — Dec 2020 [monthly]
Not Yet Recruiting PHASE1_PHASE2
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Sep 2020 — Oct 2020 [monthly]
Not Yet Recruiting PHASE1_PHASE2
First recorded
Eligibility Summary
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.
Contact Information
- Anthony Lembo
For direct contact, visit the study record on ClinicalTrials.gov .