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NCT05709717
Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases
Conditions: Perianal Fistula, Perianal Crohn Disease, Anal Fissure, Rectovaginal Fistula, Perianal Fistula Due to Crohn's Disease
Sex: All
Ages: 16 Years – N/A
Enrollment: 50
Sponsor: Kantonsspital Winterthur KSW
Location: Switzerland
Summary
Consecutive patients with complex anal fistula were prospectively followed for 12 months.
Routine MRI was performed before and at 4 and 12 months after surgery.
Continence was assessed likewise using a validated questionnaire.
Fistula were drained with setons prior surgery.
SVF was harvested from subcutaneous abdominal fat and PRP from peripheral blood.
Distal fistulectomy to the sphincter was performed and the wound left open, while the internal orifice was closed.
SVF-PRP was injected around the fistula.
Patients showered their excision wound until dry.
Outcomes were reported as median & interquartile range (IQR)
Eligibility Criteria
Inclusion Criteria:Perianal fistula Perianal fissure Anovaginal fistula Rectovaginal fistula Perianal Crohn's diseaseExclusion Criteria:-
Source: ClinicalTrials.gov (NCT05709717). StuddyBuddy aggregates publicly available trial information.
