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Autologous Cell Therapy for Treatment of Fecal Incontinence

Primary Purpose

Fecal Incontinence

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Autologous Muscle-Derived Cells (AMDC)

About this trial

This is an interventional treatment trial for Fecal Incontinence focused on measuring Cell Therapy, Autologous Cell Transplantation, Muscle-derived Cell, Anal Incontinence, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Urinary Incontinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Paul's Hospital
Royal London Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous Muscle-Derived Cells

Arm Description

Cell Treatment

Outcomes

Primary Outcome Measures

Incidence of Treatment-Related Adverse Events

Secondary Outcome Measures

Frequency of Incontinent Episodes

Incontinence Score

Sphincter Pressure

Fecal Incontinence Quality of Life Scale (FIQL)

Full Information

NCT ID

NCT01600755

First Posted

May 11, 2012

Last Updated

December 9, 2021

Sponsor

Cook MyoSite

1. Study Identification

Unique Protocol Identification Number

NCT01600755

Brief Title

Autologous Cell Therapy for Treatment of Fecal Incontinence

Official Title

A Prospective Nonrandomized Study of Autologous Muscle Derived Cell (AMDC) Transplantation for Treatment of Fecal Incontinence

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

May 2012 (Actual)

Primary Completion Date

October 27, 2021 (Actual)

Study Completion Date

October 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cook MyoSite

4. Oversight

5. Study Description

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.

Detailed Description

This study is designed to test the safety and feasibility of Autologous Muscle Derived Cells (AMDC) as a treatment for fecal incontinence in men and women. AMDC therapy seeks to allow remodeling of the external anal sphincter in patients with fecal incontinence from either defined structural defects to or a generalized weakening of the external anal sphincter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fecal Incontinence

Keywords

Cell Therapy, Autologous Cell Transplantation, Muscle-derived Cell, Anal Incontinence, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Urinary Incontinence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autologous Muscle-Derived Cells

Arm Type

Experimental

Arm Description

Cell Treatment

Intervention Type

Biological

Intervention Name(s)

Autologous Muscle-Derived Cells (AMDC)

Intervention Description

Cell Treatment

Primary Outcome Measure Information:

Title

Incidence of Treatment-Related Adverse Events

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Frequency of Incontinent Episodes

Time Frame

12 Months

Title

Incontinence Score

Time Frame

12 Months

Title

Sphincter Pressure

Time Frame

12 Months

Title

Fecal Incontinence Quality of Life Scale (FIQL)

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manoj J Raval, MD

Organizational Affiliation

St. Paul's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Paul's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6Z 1Y6

Country

Canada

Facility Name

Royal London Hospital

City

London

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Autologous Cell Therapy for Treatment of Fecal Incontinence

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