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

NCT05709717 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2023-02-02

No results posted yet for this study

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

Interventions

PROCEDURE

Regenerative therapy with SVF-PRP to supplement perianal surgery

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

Sponsors & Collaborators

  • Kantonsspital Winterthur KSW

    lead OTHER

Principal Investigators

  • Michel Adamina, MD, PD, MSc, EMBA HSG · Chief of Colorectal Surgery

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-25
Primary Completion
2023-12-31
Completion
2024-01-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05709717 on ClinicalTrials.gov