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Autologous Cell Therapy for Treatment of Fecal Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01600755
Recruitment Status : Recruiting
First Posted : May 17, 2012
Last Update Posted : December 2, 2017
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook MyoSite )

Brief Summary:
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 or disease Intervention/treatment Phase
Fecal Incontinence Biological: AMDC Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Study Start Date : May 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AMDC Biological: AMDC
Cell Treatment

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

Secondary Outcome Measures :
  1. Frequency of incontinent episodes [ Time Frame: 12 Months ]
  2. Incontinence score [ Time Frame: 12 Months ]
  3. Sphincter pressure [ Time Frame: 12 Months ]
  4. Quality of life [ Time Frame: 12 months ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01600755

Contact: Yahira Baez-Santos, PhD 800-356-9208 yahira.baez-santos@cookmedical.com

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 London Hospital Recruiting
London, United Kingdom
Contact: Charles Knowles, Prof    +44(0)2078828757      
Sponsors and Collaborators
Cook MyoSite

Responsible Party: Cook MyoSite
ClinicalTrials.gov Identifier: NCT01600755     History of Changes
Other Study ID Numbers: 09-025
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: December 2, 2017
Last Verified: November 2017

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