Amnion cell derivatives for fistulising perianal Crohn’s disease

This intervention requires one or two injections (six to eight weeks apart) of derivatives from 40 million human amnion epithelial cells per fistula into perianal fistulas. The human amnion epithelial cells were obtained from the placentas of healthy consenting donors delivering at-term healthy babies at Monash Health obtained under Good-Manufacturing Practice-like conditions for clinical trial use. After the initial treatment injection, if fistula healing is not achieved by week 6 (from intervention) based on clinical examination, then a second dose of stem cell derivative will be injected. For all injections, the dosage administered is 6 ml of derivative solution per fistula (up to a maximum of 3 fistulas per patient i.e. 18 ml solution) which will be injected along the fistula tract. These injections will be undertaken during an examination under anaesthesia surgical procedure performed by a specialist colorectal surgeon in an operating theatre at our quaternary Australian hospital and take approximately 1 hour. Prior to fistula injection, all setons must be removed and the internal fistula opening closed with sutures to allow for healing. There anaesthesia administered will be a general anaesthesia which is routine for perianal fistula examination under anaesthesia. The procedure will be recorded in a procedural report.