Autologous Cell Therapy for Treatment of Fecal Incontinence
This study is currently recruiting participants.
Verified March 2013 by Cook
Sponsor:
Cook MyoSite
Information provided by (Responsible Party):
Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier:
NCT01600755
First received: May 11, 2012
Last updated: March 19, 2013
Last verified: March 2013
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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: | April 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 | |
| Canada, Quebec | |
| Jewish General Hospital | Recruiting |
| Montreal, Quebec, Canada, H3T 1E2 | |
| Contact: Philip H. Gordon, MD 514-342-1772 | |
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: | March 19, 2013 |
| 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 May 22, 2013