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Autologous Cell Therapy for Treatment of Fecal Incontinence

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Cook Group Incorporated ( Cook MyoSite )
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook MyoSite ) Identifier:
First received: May 11, 2012
Last updated: November 10, 2016
Last verified: October 2016
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC; a preparation of a patient's own cells) injection into the anal sphincter for treatment of patients with fecal incontinence.

Condition Intervention Phase
Fecal Incontinence Biological: AMDC Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Nonrandomized Study of Autologous Muscle Derived Cell (AMDC) Transplantation for Treatment of Fecal Incontinence

Resource links provided by NLM:

Further study details as provided by Cook Group Incorporated ( Cook MyoSite ):

Primary Outcome Measures:
  • Incidence of treatment-related adverse events [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Frequency of incontinent episodes [ Time Frame: 12 Months ]
  • Incontinence score [ Time Frame: 12 Months ]
  • Sphincter pressure [ Time Frame: 12 Months ]
  • Quality of life [ Time Frame: 12 months ]

Estimated Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMDC Biological: AMDC
Cell Treatment


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary symptoms of fecal incontinence, as confirmed by patient medical history and physical examination
  • Wexner score ≥ 9
  • Failed conservative treatment

Exclusion Criteria:

  • Gracilis sling repair or insertion of an artificial sphincter
  • Inflammatory Bowel Disease
  • Significant rectocele or rectal prolapse
  • History of radiation treatment to the anal sphincter or adjacent structures
  • Less than 18 years of age
  • Pregnant, breastfeeding, or plans to become pregnant during the course of the study
  • Neuromuscular disorder
  • History of neoplasia within 5 years prior to enrollment, except for basal cell carcinoma, or is receiving or planning to receive anti-cancer medications
  • Known bleeding diathesis or uncorrected coagulopathy
  • Medical condition that would preclude treatment due to contraindications and/or warnings of concomitant medications or listed in the experimental product labeling
  • Participating in another investigational drug or device study
  • Unable or unwilling to provide informed consent
  • Unable or unwilling to commit to the follow-up procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01600755

Contact: Yahira Baez-Santos, PhD 800-356-9208

Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Manoj J. Raval, MD    604-806-8711      
United Kingdom
Royal Hospital of London, National Centre for Bowel Research & Surgical Innovation Recruiting
London, United Kingdom
Contact: Charles Knowles, Prof    +44(0)2078828757      
Sponsors and Collaborators
Cook MyoSite
  More Information

Responsible Party: Cook MyoSite Identifier: NCT01600755     History of Changes
Other Study ID Numbers: 09-025
Study First Received: May 11, 2012
Last Updated: November 10, 2016

Keywords provided by Cook Group Incorporated ( Cook MyoSite ):
Cell Therapy
Autologous Cell Transplantation
Muscle-derived Cell
Anal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Urinary Incontinence

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on September 21, 2017