Autologous Cell Therapy for Treatment of Fecal Incontinence

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier:
NCT01600755
First received: May 11, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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: 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:

Primary Outcome Measures:
  • Incidence of treatment-related adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of incontinent episodes [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Incontinence score [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Sphincter pressure [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 12 months ]

Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMDC Biological: AMDC
Cell Treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary symptoms of fecal incontinence, as confirmed by patient medical history and physical examination
  • Wexner score ≥ 5
  • 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 ClinicalTrials.gov identifier: NCT01600755

Contacts
Contact: Mette Aamand Sørensen +45 56868942 mette.aamand@cookmedical.com

Locations
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

No publications provided

Responsible Party: Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier: NCT01600755     History of Changes
Other Study ID Numbers: 09-025
Study First Received: May 11, 2012
Last Updated: July 15, 2014
Health Authority: Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cook:
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

ClinicalTrials.gov processed this record on July 29, 2014