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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

Status unknown Last updated 2 February 2023
What this trial tests

trial testing Regenerative therapy with SVF-PRP to supplement perianal surgery in Perianal Fistula in 50 participants. Status unknown.

Timeline
25 January 2023
Primary endpoint
31 December 2023
31 January 2024

Quick facts

Lead sponsorKantonsspital Winterthur KSW
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment50
Start date25 January 2023
Primary completion31 December 2023
Estimated completion31 January 2024
Sites1 location across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

Kantonsspital Winterthur KSW — full company profile →

Who can join

16 and older, any sex, with Perianal Fistula or Perianal Crohn Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Systematic review and meta-analysis of the efficacy and safety of stem cell treatment of anal fistulas.
    Emile SH, Dourado J, Rogers P, Wignakumar A, et al · · 2025 · cited 5× · PMID 40205247 · DOI 10.1007/s10151-025-03138-y
  2. Addition of Platelet-Rich Plasma to Endorectal Advancement Flap Repair Does Not Enhance the Healing of Cryptoglandular Transsphincteric Fistulas.
    Bak MTJ, Bak MTJ, Arkenbosch JHC, Becker MAJ, et al · · 2024 · cited 4× · PMID 38701430 · DOI 10.1097/dcr.0000000000003312

Verify or expand the search:

Other recruiting trials for Perianal Fistula

Currently open trials in the same condition.

Other Kantonsspital Winterthur KSW trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05709717.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing