Purpose

This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury. Half of the participants will receive iltamiocel (injections with cells) and the other half will receive placebo.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult female ≥ 18 years of age who has primary symptoms of fecal incontinence (FI) for at least 12 months. - History of obstetric anal sphincter injury (e.g., episiotomy, perineal tear). - Failed conservative treatment (e.g., dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 6 months prior to enrollment. - Must be willing and able to comply with the study procedures, be mentally competent and able to understand all study requirements, and must agree to read and sign the informed consent form prior to any study-related procedures.

Exclusion Criteria

  • Has an implanted stimulation neuromodulation system (sacral or tibial) and symptoms are unstable as determined by the physician. - Is pregnant or planning to become pregnant within the next 2 years. - Has known rectal sensory dysfunction (e.g., hypersensitivity or hyposensitivity). - Has an obstetric anal sphincter injury (e.g., episiotomy, perineal tear) within 1 year previous to study enrollment. - Patient BMI ≥ 38. - Has a history of cancer in the colorectal or pelvic organs within 5 years prior to study enrollment. - Any cancer that has undergone treatment within the past 12 months. - Has an established diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis) or current intestinal stoma. - Has grade III/IV hemorrhoids. - Has chronic diarrhea at the time of Screening. - Has chronic constipation at the time of Screening. - Has significant pelvic floor prolapse, significant genitourinary prolapse beyond the introitus, significant symptomatic rectocele, or evidence of significant rectal evacuation disorder leading to post-defecatory leakage.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Iltamiocel
  • Biological: Iltamiocel
    Single external anal sphincter (EAS) injection of 300 x 10^6 cells.
Placebo Comparator
Placebo
  • Other: Placebo
    Placebo control is the vehicle solution used for the study product.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Cook MyoSite

Study Contact

Melissa DeBoer
508-306-6288
Melissa.DeBoer@veristat.com

Detailed Description

Chronic fecal incontinence (FI) is the recurrent unintended passage of mucus and/or liquid or solid stool for at least 6 months. Iltamiocel is an investigational cell therapy product that involves a medical procedure in which a participant's own muscle cells are collected, processed, and then injected into the tissues of the external anal sphincter. This is a double-blind randomized study, which means neither the participant, nor the study doctor will know which treatment group the participant will be in. Participants who are randomly chosen to receive injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.