Autologous Cell Therapy for Treatment of Fecal Incontinence

NCT01600755 | Completed Phase 1 Results

• 1 other identifier: 09-025
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Fecal Incontinence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary)

  3, 6, and 12 months post-treatment

• Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary)

  3, 6, and 12 months post-treatment

• Number of Participants With Categorical ≥50% Reduction in 28-day Fecal Incontinence Episodes

  3, 6, and 12 months post-treatment

• Number of Participants With Categorical ≥75% Reduction in 28-day Fecal Incontinence Episodes

  3, 6, and 12 months post-treatment

• Number of Participants With 100% Reduction in 28-day Fecal Incontinence Episodes

  3, 6, and 12 months post-treatment

Study Arms (1)

Iltamiocel

EXPERIMENTAL

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

Biological: Iltamiocel

Interventions

Iltamiocel BIOLOGICAL

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

Also known as: Autologous Muscle-Derived Cells (AMDC)

Iltamiocel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cook MyoSite: lead

Study Sites (2)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Royal London Hospital

London, United Kingdom

Location

Related 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. Epub 2023 May 5.

  PMID: 37144409 RESULT

MeSH Terms

Conditions

Fecal Incontinence; Encopresis; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Urinary Incontinence

Condition Hierarchy (Ancestors)

Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Elimination Disorders; Mental Disorders; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations

Results Point of Contact

• Title: Ron Jankowski, PhD
• Organization: Cook MyoSite Incorporated

Ron.Jankowski@CookMyosite.com

412-963-7380

Study Officials

• Manoj J Raval, MD

  St. Paul's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 17, 2012
• Study Start: March 28, 2013
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: February 16, 2024
• Results First Posted: February 16, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); CA (1)