Fecal IncontinencePhase 3DigniFINCT05776277
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury
A Phase 3 study testing Iltamiocel in people with Fecal Incontinence, run by Cook MyoSite at 25 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fecal Incontinence
- What is being tested?
- Iltamiocel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 25 sitesUnited States
- Study dates
- 21 Mar 2024to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Illinois
Chicago, Illinois, 60612
Cleveland Clinic Main Campus Crile Building
Cleveland, Ohio, 44195
Colorectal Wellness Center
Fayetteville, Georgia, 30214
University of Florida Shands Hospital
Gainesville, Florida, 32610
Bennett Institute of Urogynecology and Incontinence
Grand Rapids, Michigan, 49546
Westchester Medical Center
Hawthorne, New York, 10532
Franciscan Health Indianapolis
Indianapolis, Indiana, 46237
UC San Diego Health
La Jolla, California, 92122
Healthcare Clinical Data, Inc.
Miami, Florida, 33161
University of Minnesota
Minneapolis, Minnesota, 55455
Rutgers, Robert Wood Johnson Medical School, Clinical Research Center
New Brunswick, New Jersey, 08901
Ochsner Health
New Orleans, Louisiana, 70121
The Mount Sinai Medical Center
New York, New York, 10029
Weill Cornell Medicine
New York, New York, 10065
UC Irvine Medical Center
Orange, California, 92868
Orlando Health Colon & Rectal Institute
Orlando, Florida, 32806
Rhode Island Hospital
Providence, Rhode Island, 02903
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Francisco - Center for Colorectal Surgery
San Francisco, California, 94158
Washington University School of Medicine
St Louis, Missouri, 63110
Stony Brook University Hospital
Stony Brook, New York, 11794
USF Health South Tampa Center for Advanced Healthcare
Tampa, Florida, 33606
Prestige Medical Group
Tustin, California, 92780
American Association of Female Pelvic Medicine
Westlake Village, California, 91361
About this study
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)
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.
Read the 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).
- Conditions
- Fecal Incontinence
- Being tested
- Iltamiocel, Placebo
- Keywords
- Obstetric Trauma, Obstetric Injury, Cell Therapy, Anal Incontinence, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Bowel Incontinence
- Medical subject headings
- Fecal Incontinence, Encopresis, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IltamiocelBiological
Single external anal sphincter (EAS) injection of 300 x 10^6 cells.
PlaceboOther
Placebo control is the vehicle solution used for the study product.
| Study group | Role | What they receive |
|---|---|---|
| Iltamiocel | Experimental | Not described Receives: Biological: Iltamiocel |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in frequency of fecal incontinence episodes.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start21 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cook MyoSite
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Jankowski, PhD, Study director, Cook Myosite, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776277
- Sponsor's protocol ID
- 22-01
- Acronym
- DigniFI
- Status last verified
- Oct 2026
- First submitted
- 8 Mar 2023
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05776277
- Acronym / sponsor ID
- DigniFI / 22-01
- Conditions
- Fecal Incontinence
- Keywords
- Obstetric Trauma, Obstetric Injury, Cell Therapy, Anal Incontinence, Rectal Diseases, Intestinal Diseases, Gastrointestinal Diseases, Bowel Incontinence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cook MyoSiteIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iltamiocel | Experimental | Biological: Iltamiocel |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IltamiocelSingle external anal sphincter (EAS) injection of 300 x 10^6 cells. | Biological | Iltamiocel |
| PlaceboPlacebo control is the vehicle solution used for the study product. | Other | Placebo |
Primary outcome
Changes in frequency of fecal incontinence episodes.
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Fecal Incontinence
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Acute Genital Nerve Stimulation for Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
Fecal Incontinence
Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Spinal Cord Injury
Recruiting
Postpartum Health Trajectories the First Year After Obstetric Anal Sphincter Injury and the Impact of a Group-Based Intervention
Obstetric Anal Sphincter Injury
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ron Jankowski, PhD study director
Cook Myosite, Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iltamiocel in people with Fecal Incontinence, run by Cook MyoSite at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in frequency of fecal incontinence episodes. (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.