Local fistula injection of allogeneic human amnion epithelial cells is safe and well tolerated in patients with refractory complex perianal Crohn's disease: a phase I open label study with long-term follow up.

"Declaration of interests A provisional patent (AU2022901083) has been filed in Australia for use of human amnion epithelial cells in perianal fistulising Crohn's disease with RL, CK and GM listed as co-inventors. A company (Exosome Biosciences Pty Ltd 2023) co-owned by the Hudson Institute of Medical Research, Monash University and Monash Health has been established using derivatives of human amnion epithelial cells to treat Crohn's disease. The authors have not received any monetary payments from the company and this company had no role in any part of this study. WS, RL, CK, TCN and GM will participate in a future clinical trial affiliated with Exosome Biosciences. AG has nothing to declare."

"This study was funded by competitive research grant funding from the 10.13039/501100001202Gastroenterological Society of Australia Seed Grant 2018. The funding organisation had no role in any of the study design, collection, analysis or interpretation of the data, writing of the report and decision to submit the paper for publication."

"Ethics approval was granted by the Monash Health Human Research Ethics Committee (HREC) to perform this study (HREC/18/MonH/342, 18-0000-225A) under the requirements of the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research. The investigational product was approved by the Therapeutic Goods Administration (TGA) Clinical Trial Notification scheme. The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) prior to commencement (ACTRN 12618001883202) and overseen by an independent Data Safety Monitoring Board (DSMB). Written informed consent was obtained from all participants prior to enrollment in the study."