Autologous Cell Therapy for Treatment of Fecal Incontinence

Cook Group

Status and phase: Completed; Phase 2; Phase 1

Conditions: Fecal Incontinence

Treatments: Biological: Iltamiocel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01600755

09-025

Details and patient eligibility

About

The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment of patients with fecal incontinence.

Full description

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

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary symptoms of fecal incontinence, as confirmed by patient medical history and physical examination
• Wexner (Cleveland Clinic Incontinence Severity (CCIS)) score ≥ 9
• Etiology of fecal incontinence is related, at least in part, to external anal sphincter dysfunction
• 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
• Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

Iltamiocel

Experimental group

Description:

AMDC is the study product (autologous muscle-derived cells). The generic name is iltamiocel. Single intrasphincteric injection of 250 x 10\^6 cells.

Treatment:

Biological: Iltamiocel