Autologous Cell Therapy for Treatment of Fecal Incontinence

This study is currently recruiting participants.
Verified February 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier:
NCT01600755
First received: May 11, 2012
Last updated: February 4, 2014
Last verified: February 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01600755

Contacts
Contact: Chris Ballas 765-463-7537 cballas@medinst.com

Locations
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Manoj J. Raval, MD    604-806-8711      
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: February 4, 2014
Health Authority: Canada: Health Canada

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 April 16, 2014