NCT04519697.

Study name	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.
Methods	Phase IB/IIA Study, RCT, Crossover Assignment Masking: Single (Participant)
Participants	40 participants, 18 Years to 75 Years, Females Patients with rectovaginal fistulas in the setting of Crohn's disease.
Interventions	Experimental: Mesenchymal Stem Cells 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. Placebo Comparator: Placebo 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.
Outcomes	Primary outcome: Treatment related adverse events [ Time Frame: Month 6 ]
Starting date	October 28, 2020
Contact information	Contact: Caroline Matyas, BSPH216‐212‐0746NCT04519697, CCF‐Stem Cells IBD‐003, Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease" type="EXTERNAL">ibdstemcelltherapy@ccf.org Contact: Kavita Elliott, BS216‐403‐3573mailto:ibdstemcelltherapy%40ccf.org?subject=NCT04519697, CCF‐Stem Cells IBD‐003, Mesenchymal Stem Cells for the Treatment of Rectovaginal Fistulas in Participants With Crohn's Disease
Notes	Estimated completion date: October 2022 Location and recruiting: Cleveland, Ohio, United States, 44195 Contact: Kavita Elliott Contact: Caroline Matyas Principal Investigator:Amy Lightner, MDThe Cleveland Clinic