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

K

Kantonsspital Winterthur KSW

Status

Not yet enrolling

Conditions

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

Treatments

Procedure: Regenerative therapy with SVF-PRP to supplement perianal surgery

Study type

Observational

Funder types

Other

Identifiers

NCT05709717
SVF-PRP

Details and patient eligibility

About

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)

Enrollment

50 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial contacts and locations

1

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Central trial contact

Michel Adamina, MD, PD, MSc, EMBA HSG; Rebekka Sterki

Data sourced from clinicaltrials.gov

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