Autologous Cell Therapy for Treatment of Fecal Incontinence

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-28

Study Completion Date

2021-10-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Fecal Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iltamiocel

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

Group Type EXPERIMENTAL

Iltamiocel

Intervention Type BIOLOGICAL

Single intrasphincteric injection of iltamiocel at a dose of 250 x 10\^6 cells

Interventions

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Iltamiocel

Single intrasphincteric injection of iltamiocel at a dose of 250 x 10\^6 cells

Intervention Type BIOLOGICAL

Other Intervention Names

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Autologous Muscle-Derived Cells (AMDC)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No