Muscle Fiber Fragment Treatment for Urinary Incontinence

Study Overview
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Brief Summary
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This study is designed to evaluate the safety of autologous muscle fiber fragments for the treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).

Detailed Description
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Eligible subjects with a diagnosis of urinary incontinence who give consent to take part will undergo a biopsy of the muscle from the inner thigh under anesthesia. During the same procedure, muscle fiber fragments will be obtained from the sample and then immediately delivered via target injected into the bladder neck sphincter region using an endoscopic needle via cystoscope or under ultrasound guidance. All subjects will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-treatment injection.

Official Title
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A Phase 1 Study of Human Muscle Fiber Fragment (MFF) Treatment for Urinary Incontinence

Conditions
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Urinary Incontinence

Intervention / Treatment
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* Other: Autologous Muscle Fiber Fragments


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female patients who are not pregnant or lactating/breast-feeding and must be either not sexually active, surgically sterilized, or must be practicing an effective method of birth control as determined by the investigator Patients between the ages of 18 and 75 years Patients with positive diagnosis of urinary incontinence due to sphincter insufficiency caused by acquired (e.g., stress urinary incontinence) and/or congenital conditions. Patients with cystometric capacity of bladder > 100 ml Patients with normal renal function Patients with a history of primary incontinence Exclusion Criteria: Patients with a history of hypercontractile bladder, non-compliant bladder, hydronephrosis or neurogenic bladder Patients with an active urinary tract infection as evidenced by positive urine culture Patients who are taking medication that affect urination such as prescription drugs, over-the-counter drugs, or dietary supplements, including herbal supplements and those taken with teas Patients requiring concomitant use of or treatment with immunosuppressive agents Patients with a history of systemic conditions, including but not limited to HIV, diabetes and chronic liver disease (including Hepatitis B or C), that the Investigator believes may jeopardize the safety of the patient to participate in the study Patients with evidence or diagnosis of any primary muscle disease or coagulation disorder (including concomitant anti-coagulation therapy) Patients who have been treated with any other investigational drug or participated in any investigational study within 30 days prior to enrollment in this study Patients who have been treated with any cellular therapy within 12 months prior to enrollment in this study Patients with urinary incontinence other than the categories being investigated Patients with significant (>grade 2) pelvic organ prolapse Patients with vaginal prolapse beyond introitus Patients with neurological disorders Patients with abnormal bladder capacity (i.e., less than 100 cc) Patients with abnormal urologic conditions, including post-void residual, urethral stricture and bladder neck contracture, spastic bladder, vesicoureteral reflux, bladder stones, bladder tumors, hydronephrosis, other renal impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous Muscle Fiber Fragments<br>Autologous Muscle Fiber Fragments administered via a single,direct injection into the bladder neck sphincter region | Other: Autologous Muscle Fiber Fragments<br>* Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of treatment-related serious adverse events | the subject/biopsy/treatment sites will be monitored for signs of bleeding, infections, continued pain, prolonged hospitalization | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Incontinence Assessment by Pad Test | Subjects will undergo 1 hour and 24 hour Pad Tests (pads are weighed) at baseline, 3, 6 and 12 months post treatment | baseline, 3, 6, and 12 months post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary incontinence, muscle fibers