Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases

Not yet recruiting

• Conditions: Anal Fissure; Perianal Crohn Disease; Perianal Fistula; Rectovaginal Fistula; Perianal Fistula Due to Crohn's Disease

• Registration Number: NCT05709717
• Lead Sponsor: Kantonsspital Winterthur KSW

Brief 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)

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-01-24
• Last Update Submitted: 2023-01-24
• Study Start: 2023-01-25
• Study First Posted: 2023-02-02
• Last Update Posted: 2023-02-02
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Perianal fistula Perianal fissure Anovaginal fistula Rectovaginal fistula Perianal Crohn's disease

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Healing	1 year	Absence of fistula opening and discharge, well-being
MRI healing	1year	Absence of active fistula and abscess

Secondary Outcome Measures

Name	Time	Method
Fecal continence	1 year	Vaizey score
Quality of life (general and related to perianal diseases)	1 year	FIQoL
Costs	1 year	Direct cost to patient, institution, and payee

Trial Locations

Locations (1)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Switzerland