Implantation of BioSphincter TM for Treatment of Severe Passive Fecal Incontinence

Summary

This is first-in-human prospective Phase I study of the immediate and long-term safety of an implanted internal anal sphincter (IAS) bioengineered from autologous cells to treat subjects with severe passive FI who have failed standard treatments.

Timeline

Start

2022-11-02

Primary completion

2027-07

Completion

2027-07

Publications

• Background Baxter NN, Rothenberger DA, Lowry AC. Measuring fecal incontinence. Dis Colon Rectum. 2003 Dec;46(12):1591-605. doi: 10.1007/BF02660762.
• Background Bharucha AE, Fletcher JG, Seide B, Riederer SJ, Zinsmeister AR. Phenotypic variation in functional disorders of defecation. Gastroenterology. 2005 May;128(5):1199-210. doi: 10.1053/j.gastro.2005.03.021.
• Background Cleveland Clinic Incontinence Score. Vol. 0, 2021, p. 1993.
• Background Engel AF, Kamm MA, Bartram CI, Nicholls RJ. Relationship of symptoms in faecal incontinence to specific sphincter abnormalities. Int J Colorectal Dis. 1995;10(3):152-5. doi: 10.1007/BF00298538.
• Background Farouk R, Duthie GS, Pryde A, McGregor AB, Bartolo DC. Internal anal sphincter dysfunction in neurogenic faecal incontinence. Br J Surg. 1993 Feb;80(2):259-61. doi: 10.1002/bjs.1800800250.
• Background Fecal Incontinence Quality of Life Scale (FIQOL). 2021.
• Background Fecal Incontinence Severity Index ( FISI ). 2021.
• Background Goode PS, Burgio KL, Halli AD, Jones RW, Richter HE, Redden DT, Baker PS, Allman RM. Prevalence and correlates of fecal incontinence in community-dwelling older adults. J Am Geriatr Soc. 2005 Apr;53(4):629-35. doi: 10.1111/j.1532-5415.2005.53211.x.
• Background Huebner M, Margulies RU, Fenner DE, Ashton-Miller JA, Bitar KN, DeLancey JO. Age effects on internal anal sphincter thickness and diameter in nulliparous females. Dis Colon Rectum. 2007 Sep;50(9):1405-11. doi: 10.1007/s10350-006-0877-7.
• Background Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97. doi: 10.1007/BF02050307.
• Background Luo C, Samaranayake CB, Plank LD, Bissett IP. Systematic review on the efficacy and safety of injectable bulking agents for passive faecal incontinence. Colorectal Dis. 2010 Apr;12(4):296-303. doi: 10.1111/j.1463-1318.2009.01828.x. Epub 2009 Mar 6.
• Background Maeda Y, Laurberg S, Norton C. Perianal injectable bulking agents as treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013 Feb 28;2013(2):CD007959. doi: 10.1002/14651858.CD007959.pub3.
• Background Norton C, Cody JD. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD002111. doi: 10.1002/14651858.CD002111.pub3.
• Background Omar MI, Alexander CE. Drug treatment for faecal incontinence in adults. Cochrane Database Syst Rev. 2013 Jun 11;2013(6):CD002116. doi: 10.1002/14651858.CD002116.pub2.
• Background Rao SS. Pathophysiology of adult fecal incontinence. Gastroenterology. 2004 Jan;126(1 Suppl 1):S14-22. doi: 10.1053/j.gastro.2003.10.013.
• Background Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7. doi: 10.1007/BF02237236.
• Background Sangwan YP, Coller JA, Schoetz DJ, Roberts PL, Murray JJ. Spectrum of abnormal rectoanal reflex patterns in patients with fecal incontinence. Dis Colon Rectum. 1996 Jan;39(1):59-65. doi: 10.1007/BF02048271.
• Background Tan JJ, Chan M, Tjandra JJ. Evolving therapy for fecal incontinence. Dis Colon Rectum. 2007 Nov;50(11):1950-67. doi: 10.1007/s10350-007-9009-2.
• Background Whitehead WE, Palsson OS, Simren M. Treating Fecal Incontinence: An Unmet Need in Primary Care Medicine. N C Med J. 2016 May-Jun;77(3):211-5. doi: 10.18043/ncm.77.3.211.
• Background Zbar AP, Khaikin M. Should we care about the internal anal sphincter? Dis Colon Rectum. 2012 Jan;55(1):105-8. doi: 10.1097/DCR.0b013e318235b645.
• Background Zutshi M, Tracey TH, Bast J, Halverson A, Na J. Ten-year outcome after anal sphincter repair for fecal incontinence. Dis Colon Rectum. 2009 Jun;52(6):1089-94. doi: 10.1007/DCR.0b013e3181a0a79c.

Drugs

Indications

No indication recorded.