What is the mechanism of action of this treatment?

Common treatments for bowel incontinence include lifestyle modifications, medications, pelvic floor exercises, and surgical interventions. Cell-based therapies, such as Iltamiocel, aim to repair or regenerate damaged anal sphincter tissue by injecting stem cells or other regenerative cells into the affected area. These cells can differentiate into muscle or nerve cells, potentially restoring the function of the sphincter. This is crucial for bowel incontinence patients as it addresses the underlying tissue damage, offering a potential long-term solution rather than just managing symptoms.

What side effects are associated with this type of intervention?

Common treatments for bowel incontinence include conservative measures like dietary changes, medications, and physical therapy, as well as more advanced options like cell-based therapies aimed at repairing or regenerating damaged anal sphincter tissue. For cell-based therapies, such as the one being studied with Iltamiocel, known side effects can include local reactions at the injection site, such as pain, swelling, and redness. There may also be risks of infection, allergic reactions, and, in rare cases, unintended tissue growth or fibrosis. It is important to discuss these potential side effects with a healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

As of now, there are no FDA-approved cell-based therapies specifically for the treatment of bowel incontinence. Traditional treatments for bowel incontinence include dietary changes, medications like loperamide, and surgical interventions. The study of Iltamiocel represents an innovative approach, aiming to repair or regenerate damaged anal sphincter tissue using cell-based therapy, which is still under investigation.

What other types of research exist?

Promising alternatives to Iltamiocel for bowel incontinence include: 1) Autologous adipose-derived mesenchymal stem cells, which have shown efficacy in treating complex perianal fistulas in Crohn's disease. 2) Platelet-rich plasma (PRP) therapy, which has been explored for its regenerative properties in various musculoskeletal injuries and may offer benefits for sphincter repair. 3) Bone marrow-derived mesenchymal stem cells, which have demonstrated improved outcomes in tendon injuries and could be adapted for sphincter regeneration.

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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 up to 5 years

Awards & highlights

Summary

This trial tests if injecting muscle cells can help women who have chronic fecal incontinence due to childbirth injuries. The goal is to see if these injections can repair and strengthen their anal muscles, reducing incontinence episodes. Previous studies have shown that injecting muscle cells into the anal muscles can significantly improve fecal incontinence, particularly in patients with childbirth-related injuries.

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bowel incontinence include lifestyle modifications, medications, pelvic floor exercises, and surgical interventions. Cell-based therapies, such as Iltamiocel, aim to repair or regenerate damaged anal sphincter tissue by injecting stem cells or other regenerative cells into the affected area. These cells can differentiate into muscle or nerve cells, potentially restoring the function of the sphincter. This is crucial for bowel incontinence patients as it addresses the underlying tissue damage, offering a potential long-term solution rather than just managing symptoms.

Find a Location

Who is running the clinical trial?

Cook MyoSiteLead Sponsor

12 Previous Clinical Trials

808 Total Patients Enrolled

Ron Jankowski, PhDStudy DirectorCook Myosite, Inc.

~133 spots leftby Sep 2026

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