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

NCT ID: NCT05709717

Last Updated: 2023-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-25

Study Completion Date

2024-01-31

Brief Summary

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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)

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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SVF-PRP

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kantonsspital Winterthur KSW

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Adamina, MD, PD, MSc, EMBA HSG

Role: PRINCIPAL_INVESTIGATOR

Chief of Colorectal Surgery

Locations

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Kantonsspital Winterthur

Winterthur, , Switzerland

Site Status

Countries

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Switzerland

Central Contacts

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Michel Adamina, MD, PD, MSc, EMBA HSG

Role: CONTACT

+41522663376

Rebekka Sterki

Role: CONTACT

+41522662040

Facility Contacts

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Michel Adamina, MD, PD, MSc, EMBA HSG

Role: primary

+41522663376

Rebekka Sterki

Role: backup

+41522662040

Other Identifiers

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SVF-PRP

Identifier Type: -

Identifier Source: org_study_id

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