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

• Sponsor: Kantonsspital Winterthur KSW (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05709717
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 12.2
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Perianal Fistula; Perianal Crohn Disease; Anal Fissure; Rectovaginal Fistula; Perianal Fistula Due to Crohn's Disease	Procedure: Regenerative therapy with SVF-PRP to supplement perianal surgery

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases
• Anticipated Study Start Date: Jan 25, 2023
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jan 31, 2024

Outcome Measures

Primary Outcome Measures

1. Clinical Healing [1 year]

   Absence of fistula opening and discharge, well-being

2. MRI healing [1year]

   Absence of active fistula and abscess

Secondary Outcome Measures

1. Fecal continence [1 year]

   Vaizey score

2. Quality of life (general and related to perianal diseases) [1 year]

   FIQoL

3. Costs [1 year]

   Direct cost to patient, institution, and payee

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kantonsspital Winterthur	Winterthur		Switzerland	8401

Sponsors and Collaborators

• Kantonsspital Winterthur KSW

Investigators

• Principal Investigator: Michel Adamina, MD, PD, MSc, EMBA HSG, Chief of Colorectal Surgery

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kantonsspital Winterthur KSW
• ClinicalTrials.gov Identifier: NCT05709717
• Other Study ID Numbers: SVF-PRP
• First Posted: Feb 2, 2023
• Last Update Posted: Feb 2, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Crohn Disease; Rectal Fistula; Fissure in Ano; Rectovaginal Fistula; Fistula

Study Results

No Results Posted as of Feb 2, 2023