Autologous Cell Therapy for Treatment of Fecal Incontinence

Fecal Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01600755
• Other study ID #: 09-025
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 28, 2013
• Est. completion date: October 27, 2021

Study information

• Verified date: June 2023
• Source: Cook MyoSite
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Biological:
• Iltamiocel
Single intrasphincteric injection of iltamiocel at a dose of 250 x 10^6 cells

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia
United Kingdom	Royal London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Cook MyoSite

Countries where clinical trial is conducted

Canada,  United Kingdom, 

References & Publications (1)

Knowles CH, Canestrari E, Jankowski RJ, Cardello K, Raval MJ. Safety and Efficacy of Iltamiocel Cellular Therapy for the Treatment of Fecal Incontinence. Results of a Phase 1/2 Study. Ann Surg. 2023 Dec 1;278(6):937-944. doi: 10.1097/SLA.0000000000005894. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatment-Related Adverse Events	Assessment of frequency and severity of adverse events related to study product and study procedures through 12 months following treatment of FI in adult male and female subjects.	12 months
Secondary	Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary)	Median number of fecal incontinence (FI) episodes as assessed by 28-day FI diary.	3, 6, and 12 months post-treatment
Secondary	Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary)	Median number of days with fecal incontinence (FI) episodes, as assessed by 28-day FI diary.	3, 6, and 12 months post-treatment
Secondary	Number of Participants With Categorical =50% Reduction in 28-day Fecal Incontinence Episodes	Number of participants with categorical =50% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary.	3, 6, and 12 months post-treatment
Secondary	Number of Participants With Categorical =75% Reduction in 28-day Fecal Incontinence Episodes	Number of participants with categorical =75% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary.	3, 6, and 12 months post-treatment
Secondary	Number of Participants With 100% Reduction in 28-day Fecal Incontinence Episodes	Number of participants with 100% reduction in fecal incontinence (FI) episodes as assessed by 28-day FI diary.	3, 6, and 12 months post-treatment
Secondary	Change From Baseline in Patient-reported Quality of Life (Fecal Incontinence Quality of Life (FIQL) Questionnaire)	Mean change from baseline in patient-reported quality of life, as assessed by the Fecal Incontinence Quality of Life (FIQL) questionnaire. The FIQL is a validated, 29-item tool assessing the quality of life (QOL) of subjects with FI with four scales: Lifestyle (10 items, scored 0 to 4, with higher scores indicating a better QOL), Coping/Behavior (9 items, scored 0 to 4, with higher scores indicating a better QOL), Depression/Self-Perception (7 items, scored 0 to 4, with higher scores indicating a better QOL), and Embarrassment (3 items, scored 0 to 4, with higher scores indicating a better QOL).	3, 6, and 12 months post-treatment
Secondary	Change From Baseline in Patient-reported Fecal Incontinence Symptom Severity (Cleveland Clinic Incontinence Score (CCIS))	Mean change from baseline in patient-reported fecal incontinence symptom severity, as assessed by the Cleveland Clinic Incontinence Score (CCIS) questionnaire. CCIS is a validated 5-questions tool assessing the frequency and the type of incontinence episodes (solid, liquid, gas), pad use, and lifestyle alteration. Scored from 0 to 20, with lower scores indicating less severe symptoms.	3, 6, and 12 months post-treatment