What is the mechanism of action of this treatment?

Common treatments for stress incontinence include pelvic floor muscle training, surgical interventions like sling procedures, and injectable bulking agents. The mechanism of action for autologous muscle-derived cells (AMDC-USR; iltamiocel) involves injecting these cells into the urinary sphincter to repair or strengthen it. This approach aims to restore the sphincter's function by promoting tissue regeneration and improving muscle tone. For stress incontinence patients, this matters because a stronger and more functional urinary sphincter can significantly reduce or eliminate involuntary urine leakage, thereby improving their quality of life.

What side effects are associated with this type of intervention?

Common treatments for stress incontinence that involve repairing or strengthening the urinary sphincter include autologous muscle-derived cell therapy and adipose-derived stem cell transplantation. Known side effects of these treatments can include local inflammation, pain at the injection site, and potential infection. Additionally, there may be risks of urinary retention or worsening incontinence if the procedure does not achieve the desired effect. As with any cellular therapy, there is also a theoretical risk of immune reactions or unintended tissue growth.

What prior FDA approvals exist?

There is limited information on FDA-approved treatments specifically using autologous muscle-derived cells for urinary sphincter repair in stress incontinence. However, traditional FDA-approved treatments for stress incontinence include surgical options like sling procedures and bulking agents that aim to support or strengthen the urinary sphincter. These treatments do not typically involve cell-based therapies. The study of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR; iltamiocel) represents an innovative approach that is still under investigation.

What other types of research exist?

Promising novel alternatives to AMDC-USR for stress incontinence patients include: 1) Stem cell therapies, such as the use of mesenchymal stem cells (MSCs) which have shown potential in regenerative medicine for various conditions. 2) Exosome therapy, which leverages the regenerative properties of exosomes derived from stem cells. 3) Gene therapy approaches that aim to repair or enhance the function of the urinary sphincter. 4) Tissue engineering techniques that involve the creation of bioengineered sphincter tissues. These alternatives are in various stages of research and clinical trials, showing potential for future application in treating stress incontinence.

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Cell Therapy

Cell-Based Therapy for Stress Urinary Incontinence (CELLEBRATE Trial)

Phase 3

Recruiting

Led By Melissa Kaufman, M.D., Ph.D.

Research Sponsored by Cook MyoSite

Eligibility Criteria Checklist

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

Must have

Adult female patient ≥ 18 years of age who has primary and moderate-to-severe symptoms of SUI for at least 6 months, as confirmed by patient medical history and clinical symptoms, including a focused incontinence evaluation

History of previous surgery for treatment of SUI. Previous surgery could include midurethral sling, retropubic suspension, or bladder neck sling. Bulking agents alone are not considered previous surgery for treatment of SUI

Must not have

Patient BMI ≥ 35

Patient has had stress urinary incontinence symptoms less than 6 months prior to signing the informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Pivotal Trial

Summary

This trial tests a new treatment for women who still have urine leakage after surgery. The treatment uses their own muscle cells, which are injected into the urinary passage to help strengthen it. The goal is to reduce accidental urine leakage during activities like laughing or coughing. Muscle-derived cells have been previously used in treatments for urinary incontinence, showing promise in improving urethral closure and reducing symptoms.

Who is the study for?

This trial is for adult women over 18 who have moderate-to-severe stress urinary incontinence despite having surgery for it. They must not be pregnant, planning pregnancy, or breastfeeding, and should not have a BMI of 35 or higher. Participants need to have tried other treatments like pelvic exercises and cannot be on certain medications affecting the bladder.

What is being tested?

The study tests Autologous Muscle Derived Cells (AMDC-USR) against a placebo in reducing stress incontinence episodes. Women will randomly receive either cell injections or a placebo to see which is more effective at treating their condition after previous surgeries failed.

What are the potential side effects?

While specific side effects are not listed here, typical risks may include injection site reactions, potential discomfort from the procedure, and possible immune response to autologous cells if they're recognized as foreign by the body.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman over 18 with severe bladder control issues for 6+ months.

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I have had surgery for stress urinary incontinence before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My BMI is 35 or higher.

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I have experienced stress urinary incontinence for less than 6 months.

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I have had cancer in my pelvic area, ureters, or kidneys.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of leaks due to stress incontinence episodes, as recorded in a diary

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: AMDC-USR (iltamiocel)Experimental Treatment1 Intervention

Autologous muscle-derived cells for urinary sphincter repair (AMDC-USR; generic name: iltamiocel) is the study product.

Group II: PlaceboPlacebo Group1 Intervention

Placebo control is the vehicle solution used for the study product.

0 / 5Eligibility 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 stress incontinence include pelvic floor muscle training, surgical interventions like sling procedures, and injectable bulking agents. The mechanism of action for autologous muscle-derived cells (AMDC-USR; iltamiocel) involves injecting these cells into the urinary sphincter to repair or strengthen it. This approach aims to restore the sphincter's function by promoting tissue regeneration and improving muscle tone. For stress incontinence patients, this matters because a stronger and more functional urinary sphincter can significantly reduce or eliminate involuntary urine leakage, thereby improving their quality of life.

Improvement of urethral sphincter deficiency in female rats following autologous skeletal muscle myoblasts grafting.Persistence and survival of autologous muscle derived cells versus bovine collagen as potential treatment of stress urinary incontinence.