Trials / Unknown
UnknownNCT05709717
Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Kantonsspital Winterthur KSW · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-01-25
- Primary completion
- 2023-12-31
- Completion
- 2024-01-31
- First posted
- 2023-02-02
- Last updated
- 2023-02-02
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT05709717. Inclusion in this directory is not an endorsement.