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Treatment of Complex Anal Fistulas Using Centrifuged Adipose Tissue Containing Progenitor Cells

NCT04326907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-03-30

No results posted yet for this study

Summary

In the treatment of complex anal fistulas transplant of freshly collected autologous adipose tissue mechanically fragmented or centrifuged adipose tissue (CAT) might be an alternative to in vitro expanded autologous or allogeneic adipose-derived stem cells, showing remarkable efficacy in diverse therapeutic indications.

The aim of our study is to evaluate randomly the efficacy and safety of the use of CAT in the healing process of complex anal fistulas, except for Crohn's disease (CD) related fistulas.

Conditions

  • Anal Fistula

Interventions

PROCEDURE

Autologous centrifuged adipose tissue (CAT) injection after anal fistulectomy

Collection and injection of autologous adipose tissue in complex anal fistulas in one surgical step under locoregional or general anesthesia.

Sponsors & Collaborators

  • University Hospital of Ferrara

    lead OTHER

Principal Investigators

  • Simona Ascanelli, MD · University Hospital Ferrara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-01
Primary Completion
2019-05-01
Completion
2019-10-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04326907 on ClinicalTrials.gov