Phase 2
N=53
Autologous Cell Therapy for Treatment of Fecal Incontinence
Fecal Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT01600755 ↗Enrolled (actual)
53
Serious AEs
7.6%
Results posted
Feb 2024
Primary outcome: Primary: Number of Treatment-Related Adverse Events — 0; 1; 5; 28 events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Iltamiocel (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook MyoSite
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Treatment-Related Adverse Events |
0; 1; 5; 28 | — |
| SECONDARY Number of Fecal Incontinence (FI) Episodes (Median 28-day Fecal Incontinence Diary) |
8; 10; 7 | — |
| SECONDARY Number of Days With FI Episodes (Median 28-day Fecal Incontinence Diary) |
7; 7; 5 | — |
| SECONDARY Number of Participants With Categorical ≥50% Reduction in 28-day Fecal Incontinence Episodes |
17; 19; 22 | — |
| SECONDARY Number of Participants With Categorical ≥75% Reduction in 28-day Fecal Incontinence Episodes |
7; 12; 16 | — |
| SECONDARY Number of Participants With 100% Reduction in 28-day Fecal Incontinence Episodes |
1; 4; 10 | — |
| SECONDARY Change From Baseline in Patient-reported Quality of Life (Fecal Incontinence Quality of Life (FIQL) Questionnaire) |
0.4; 0.4; 0.6; 0.4; 0.5; 0.5 | — |
| SECONDARY Change From Baseline in Patient-reported Fecal Incontinence Symptom Severity (Cleveland Clinic Incontinence Score (CCIS)) |
-2.2; -2.0; -2.9 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01600755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.