ACTIVE_NOT_RECRUITING

Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Two-stage, Randomized, Controlled Trial Comparing the Safety and Efficacy of Iltamiocel With Placebo in the Treatment of Female Participants With Chronic Fecal Incontinence and a History of Obstetric Anal Sphincter Injury (DigniFI)

Quick Facts

Study Start:2024-03-21
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05776277

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult female ≥ 18 years of age who has primary symptoms of fecal incontinence (FI) for at least 12 months.
  2. * History of obstetric anal sphincter injury (e.g., episiotomy, perineal tear).
  3. * Failed conservative treatment (e.g., dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 6 months prior to enrollment.
  4. * 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.
  1. * Has an implanted stimulation neuromodulation system (sacral or tibial) and symptoms are unstable as determined by the physician.
  2. * Is pregnant or planning to become pregnant within the next 2 years.
  3. * Has known rectal sensory dysfunction (e.g., hypersensitivity or hyposensitivity).
  4. * Has an obstetric anal sphincter injury (e.g., episiotomy, perineal tear) within 1 year previous to study enrollment.
  5. * Patient BMI ≥ 38.
  6. * Has a history of cancer in the colorectal or pelvic organs within 5 years prior to study enrollment.
  7. * Any cancer that has undergone treatment within the past 12 months.
  8. * Has an established diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis) or current intestinal stoma.
  9. * Has grade III/IV hemorrhoids.
  10. * Has chronic diarrhea at the time of Screening.
  11. * Has chronic constipation at the time of Screening.
  12. * 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.

Contacts and Locations

Principal Investigator

Ron Jankowski, PhD
STUDY_DIRECTOR
Cook Myosite, Inc.

Study Locations (Sites)

UC San Diego Health
La Jolla, California, 92122
United States
UC Irvine Medical Center
Orange, California, 92868
United States
University of California, San Francisco - Center for Colorectal Surgery
San Francisco, California, 94158
United States
Prestige Medical Group
Tustin, California, 92780
United States
American Association of Female Pelvic Medicine
Westlake Village, California, 91361
United States
University of Florida Shands Hospital
Gainesville, Florida, 32610
United States
Healthcare Clinical Data, Inc.
Miami, Florida, 33161
United States
Orlando Health Colon & Rectal Institute
Orlando, Florida, 32806
United States
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, 33606
United States
Colorectal Wellness Center
Fayetteville, Georgia, 30214
United States
University of Illinois
Chicago, Illinois, 60612
United States
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
United States
Ochsner Health
New Orleans, Louisiana, 70121
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Corewell Health
Grand Rapids, Michigan, 49503
United States
Bennett Institute of Urogynecology and Incontinence
Grand Rapids, Michigan, 49546
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Rutgers, Robert Wood Johnson Medical School, Clinical Research Center
New Brunswick, New Jersey, 08901
United States
Westchester Medical Center
Hawthorne, New York, 10532
United States
The Mount Sinai Medical Center
New York, New York, 10029
United States
Weill Cornell Medicine
New York, New York, 10065
United States
Stony Brook University Hospital
Stony Brook, New York, 11794
United States
Cleveland Clinic Main Campus Crile Building
Cleveland, Ohio, 44195
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States

Collaborators and Investigators

Sponsor: Cook MyoSite

  • Ron Jankowski, PhD, STUDY_DIRECTOR, Cook Myosite, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-21
Study Completion Date2027-09

Study Record Updates

Study Start Date2024-03-21
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • Obstetric Trauma
  • Obstetric Injury
  • Cell Therapy
  • Anal Incontinence
  • Rectal Diseases
  • Intestinal Diseases
  • Gastrointestinal Diseases
  • Bowel Incontinence

Additional Relevant MeSH Terms

  • Fecal Incontinence