CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 6 enrolled
Drug / intervention
ADRCs therapy +3 moreother
Likely dose
20mL Lidocaine 2% and Epinephrine 1:100 000from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02628522
NCT02628522N/ACompleted
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A Novel Method for Chronic Anal Fissure Treatment: Adipose Derived Regenerative Cells - A Pilot Study

Clinical Centre of Serbia·interventional·Posted Dec 11, 2015·Updated Dec 11, 2015

In Brief

A clinical study evaluating ADRCs therapy, Celution, and 2 other interventions for Anal Fissure. Completed, enrolled 6 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnal Fissure
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedDec 11, 2015
Enrollment StartDec 1, 2014
Primary CompletionFeb 1, 2015
Study CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.6 years ago

Interventions

ADRCs therapyother

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

Celutiondevice

Adipose derived regenerative cell isolation

Tulip cannulasdevice

Lipoaspiration

20mL Lidocaine 2% and Epinephrine 1:100 000other

Infiltration prior to liposuction