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

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ClinicalTrials.gov Identifier: NCT05709717
Recruitment Status : Not yet recruiting
First Posted : February 2, 2023
Last Update Posted : February 2, 2023
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW

Study Description
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Brief 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)

Condition or disease Intervention/treatment
Perianal Fistula Perianal Crohn Disease Anal Fissure Rectovaginal Fistula Perianal Fistula Due to Crohn's Disease Procedure: Regenerative therapy with SVF-PRP to supplement perianal surgery

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases
Estimated Study Start Date : January 25, 2023
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Groups and Cohorts
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Intervention Details:
  • 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
    Other Name: SVF-PRP

Outcome Measures
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Primary Outcome Measures :
  1. Clinical Healing [ Time Frame: 1 year ]
    Absence of fistula opening and discharge, well-being

  2. MRI healing [ Time Frame: 1year ]
    Absence of active fistula and abscess


Secondary Outcome Measures :
  1. Fecal continence [ Time Frame: 1 year ]
    Vaizey score

  2. Quality of life (general and related to perianal diseases) [ Time Frame: 1 year ]
    FIQoL

  3. Costs [ Time Frame: 1 year ]
    Direct cost to patient, institution, and payee


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with complex perianal disease
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05709717


Contacts
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Contact: Michel Adamina, MD, PD, MSc, EMBA HSG +41522663376 michel.adamina@ksw.ch
Contact: Rebekka Sterki +41522662040 rebekka.sterki@ksw.ch

Locations
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Switzerland
Kantonsspital Winterthur
Winterthur, Switzerland, 8401
Contact: Michel Adamina, MD, PD, MSc, EMBA HSG    +41522663376    michel.adamina@ksw.ch   
Contact: Rebekka Sterki    +41522662040    rebekka.sterki@ksw.ch   
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
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Principal Investigator: Michel Adamina, MD, PD, MSc, EMBA HSG Chief of Colorectal Surgery
More Information
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Responsible Party: Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT05709717    
Other Study ID Numbers: SVF-PRP
First Posted: February 2, 2023    Key Record Dates
Last Update Posted: February 2, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Anonymized data could be shared upon reasonable request and pending ethical clearance

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Rectal Fistula
Fissure in Ano
Rectovaginal Fistula
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
 Intestinal Fistula
Digestive System Fistula
Rectal Diseases
Anus Diseases
Vaginal Fistula
Vaginal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases