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

Perianal Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05709717
• Other study ID #: SVF-PRP
• Status: Not yet recruiting
• Start date: January 25, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2023
• Source: Kantonsspital Winterthur KSW
• Contact: Michel Adamina, MD, PD, MSc, EMBA HSG
• Phone: +41522663376
• Email: michel.adamina[@]ksw.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Anal Fissure
• Crohn Disease
• Fissure in Ano
• Fistula
• Perianal Crohn Disease
• Perianal Fistula
• Rectal Fistula
• Rectovaginal Fistula

Intervention

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

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Healing	Absence of fistula opening and discharge, well-being	1 year
Primary	MRI healing	Absence of active fistula and abscess	1year
Secondary	Fecal continence	Vaizey score	1 year
Secondary	Quality of life (general and related to perianal diseases)	FIQoL	1 year
Secondary	Costs	Direct cost to patient, institution, and payee	1 year