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

NCT05709717 | Unknown

• 1 other identifier: SVF-PRP
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Clinical Healing

  Absence of fistula opening and discharge, well-being

  1 year

• MRI healing

  Absence of active fistula and abscess

  1year

Secondary Outcomes (3)

• Fecal continence

  1 year

• Quality of life (general and related to perianal diseases)

  1 year

• Costs

  1 year

Interventions

Regenerative therapy with SVF-PRP to supplement perianal surgery PROCEDURE

Regenerative therapy with autologous stromal vascular fraction derived mesenchymal stem cells and platelet-rich plasma to supplement perianal surgery

Also known as: SVF-PRP

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with complex perianal disease

You may qualify if:

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

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

Study Sites (1)

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

Location

MeSH Terms

Conditions

Fissure in Ano; Rectovaginal Fistula

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Fistula; Intestinal Fistula; Digestive System Fistula; Vaginal Fistula; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Michel Adamina, MD, PD, MSc, EMBA HSG

  Chief of Colorectal Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Adamina, MD, PD, MSc, EMBA HSG

CONTACT

+41522663376; michel.adamina@ksw.ch

Rebekka Sterki

CONTACT

+41522662040; rebekka.sterki@ksw.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: January 25, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: February 2, 2023

Record last verified: 2023-01

Locations

CH (1)