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A Novel Method for Chronic Anal Fissure Treatment

NCT02628522 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-12-11

No results posted yet for this study

Summary

Investigators performed a prospective pilot study to test the feasibility and safety of autologous adipose derived regenerative cell (ADRC) transplantation in treatment of anal fissures. The study included 6 patients with chronic anal fissures with symptoms that had an average duration of 24 months. All patients were candidates for surgical treatment as all previous conservative treatments were unsuccessful. The pain level was measured using the VAS scale and was recorded before the treatment and on every consultation following the treatment.

The initial hypothesis is that application of ADRCs may be an alternative to lateral sphincterotomy and a reliable procedure to avoid fecal incontinence.

Conditions

  • Anal Fissure

Interventions

OTHER

ADRCs therapy

Patients with chronic anal fissures will receive one treatment of local injections of fat enriched with adipose derived regenerative cells starting from December 2014.

DEVICE

Celution

Adipose derived regenerative cell isolation

DEVICE

Tulip cannulas

Lipoaspiration

OTHER

20mL Lidocaine 2% and Epinephrine 1:100 000

Infiltration prior to liposuction

Sponsors & Collaborators

  • Clinical Centre of Serbia

    lead OTHER

Principal Investigators

  • Katarina Andjelkov, MD, PhD · Clinical Centre Serbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-02-28
Completion
2015-10-31

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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 NCT02628522 on ClinicalTrials.gov