Who is sponsoring NCT02628522?

NCT02628522 is sponsored by Clinical Centre of Serbia.

What condition does NCT02628522 study?

NCT02628522 studies Anal Fissure.

What drugs are being tested in NCT02628522?

Interventions: ADRCs therapy, Celution, Tulip cannulas, 20mL Lidocaine 2% and Epinephrine 1:100 000.

What is the status of NCT02628522?

NCT02628522 is currently COMPLETED.

Last reviewed 2015-12-10 · How we verify

A Novel Method for Chronic Anal Fissure Treatment: Adipose Derived Regenerative Cells - A Pilot Study

NCT02628522 NA COMPLETED

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.

Details

Lead sponsor	Clinical Centre of Serbia
Phase	NA
Status	COMPLETED
Enrolment	6
Start date	2014-12
Completion	2015-10

Conditions

Anal Fissure

Interventions

ADRCs therapy
Celution
Tulip cannulas
20mL Lidocaine 2% and Epinephrine 1:100 000

Primary outcomes

Time to complete cessation of anal pain — 33 days