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Adipose Tissue Injection in Perianal Fistulas in Crohn´s Disease

NCT03904212 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2019-04-05

No results posted yet for this study

Summary

This randomized and placebo controlled study investigates the efficacy of injections with freshly harvested autologous adipose tissue in CD patients with complex perianal fistulas refractory to standard surgical and/or medical treatment. 140 CD patients will be included and randomized to either treatment with freshly harvested autologous adipose tissue or placebo (saline). Primary outcome measures are clinical healing 6 months after treatment evaluated by clinical examination and pelvic MRI.

Conditions

  • Crohn Disease
  • Perianal Fistulas
  • Cell- and Tissue-Based Therapy
  • Treatment

Interventions

PROCEDURE

Adipose tissue injection

Injection with freshly harvested autologous adipose tissue

PROCEDURE

saline

injection with saline

Sponsors & Collaborators

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Lilli Lundby, MD · Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-27
Primary Completion
2022-03-01
Completion
2024-03-01

Countries

  • Denmark

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 NCT03904212 on ClinicalTrials.gov