A novel method for treatment of chronic anal fissure: adipose-derived regenerative cells - a pilot study.

ABSTRACT

AIM: The purpose of this study was to investigate the safety and feasibility of autologous adipose-derived regenerative cells (ADRC) in the treatment of chronic anal fissure. METHOD: A prospective pilot study was conducted in six patients with chronic anal fissures at the First Surgical Clinic, Clinical Center of Serbia and at the BelPrime Clinic, Belgrade, Serbia. All patients were candidates for surgical treatment. The average duration of symptoms was 24 months. Pain assessment was quantified using a visual analogue scale and bowel continence was assessed using the Wexner incontinence score. Both were assessed before treatment and during each postoperative outpatient visit. Liposuction was performed under local or general anaesthesia. Extraction of ADRC was achieved with a closed automated medical device. The fat and ADRC were injected subcutaneously into the edge of the fissure. The rest of the pellet was infiltrated into the internal anal sphincter. The study has been registered at ClinicalTrials.gov (NCT02628522). RESULTS: Complete healing of the anal fissure and the disappearance of symptoms was achieved in all patients. The average time to complete pain cessation was 33.7 ± 15.0 days. All fissures healed after 3 months and remained healed 12 months after the procedure. There were no complications related to the procedure. CONCLUSION: The application of ADRC may be an alternative to lateral sphincterotomy and a reliable procedure which avoids faecal incontinence.