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Cell Therapy

Iltamiocel for Bowel Incontinence (DigniFI Trial)

Phase 3

Recruiting

Research Sponsored by Cook MyoSite

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Failed conservative treatment (e.g., dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 6 months prior to enrollment.

Adult female ≥ 18 years of age who has primary symptoms of fecal incontinence (FI) for at least 12 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

DigniFI Trial Summary

This trial studies how injections of cells can reduce fecal incontinence episodes in women who have had an anal sphincter injury after childbirth.

Who is the study for?

This trial is for adult women over 18 with chronic fecal incontinence due to childbirth injuries. They must have tried other treatments like diet changes or pelvic exercises for at least 6 months without success and score ≥9 on a specific incontinence scale.Check my eligibility

What is being tested?

The study tests the effectiveness of a single injection of Iltamiocel (a cell therapy) versus a placebo in reducing episodes of bowel leakage. Participants are randomly divided into two groups, one receiving Iltamiocel and the other a placebo.See study design

What are the potential side effects?

Potential side effects were not provided but may include reactions at the injection site, immune responses, or infection risks associated with any injectable treatment.

DigniFI Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have tried treatments like diet changes and medications for my condition for over 6 months without success.

Select...

I am a woman over 18 with symptoms of fecal incontinence for at least a year.

DigniFI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in frequency of fecal incontinence episodes.

Side effects data

From 2020 Phase 3 trial • 311 Patients • NCT01893138

18%

Urinary tract infection

10%

Dysuria

Sinusitis

Injection site pain

Back pain

Pancreatitis

Hypersensitivity

Pyelonephritis

Scoliosis

Spondylolisthesis

Acute respiratory failure

Atelectasis

Procedural Pain

Sepsis

Staphylococcal infection

Pneumonia

Papillary thyroid cancer

Coronary artery dissection

Viral infection

Intervertebral disc degeneration

Pain in extremity

Major depression

Suicide attempt

100%

80%

60%

40%

20%

Study treatment Arm

Iltamiocel - Double-Blind Period

Placebo - Double-Blind Period

Iltamiocel - Unblinded Period

Placebo Receiving Open Label Iltamiocel in Unblinded Period

DigniFI Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IltamiocelExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Iltamiocel

2013

Completed Phase 3

~370

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cook MyoSiteLead Sponsor

12 Previous Clinical Trials

832 Total Patients Enrolled

Ron Jankowski, PhDStudy DirectorCook Myosite, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants still being accepted for this experiment?

"According to information provided on clinicaltrials.gov, this medical experiment is actively seeking volunteers and has been since its inception on December 1st 2023. The details have most recently been revised as of November 28th 2023."

Answered by AI

Has Iltamiocel been given the green light by the FDA?

"Assessing the safety of Iltamiocel, our team at Power gave it a score of 3. This is due to its Phase 3 trial status which implies that there are some efficacy data and multiple stages of safety research conducted beforehand."

Answered by AI

What is the size of the participant pool in this research endeavor?

"Affirmative. Clinicaltrials.gov reports that this clinical trial is still enrolling participants since it was first announced on December 1st 2023, and updated most recently on November 28th 2023. 200 patients are needed for the research at one medical site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776277.