Autologous Cell Therapy for Treatment of Fecal Incontinence

Phase 1/2 Completed 53 enrolled Cook MyoSite

NaSingle-groupOpen-labelTreatment

Summary

The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment of patients with fecal incontinence.

Timeline

Start: 2013-03-28
Primary completion: 2021-10-27
Completion: 2021-10-27

Publications

Results Knowles CH, Canestrari E, Jankowski RJ, Cardello K, Raval MJ. Safety and Efficacy of Iltamiocel Cellular Therapy for the Treatment of Fecal Incontinence. Results of a Phase 1/2 Study. Ann Surg. 2023 Dec 1;278(6):937-944. doi: 10.1097/SLA.0000000000005894. Epub 2023 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iltamiocel	Cell therapy	2.5e+08 cells	Other

Indications

No indication recorded.