Urinary Incontinence
Conditions
Keywords
urinary incontinence, muscle progenitor cells, MPCs
Brief summary
This study is designed to evaluate the safety of muscle progenitor cells (MPCs) for the treatment of urinary incontinence due to incompetent outlet (bladder neck/urethra).
Detailed description
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. The muscle sample will be cultured and expanded for approximately 6 weeks. The product, composed of autologous, ex vivo-expanded muscle progenitor cells (MPCs) in suspension, will be delivered via targeted injection into the bladder neck sphincter region using either an endoscopic needle via a cystoscope or periurethral injection under ultrasound guidance. All subjects will be followed at 1 week, 6 weeks, 3 months, 6 months and 12 months post-injection.
Interventions
BIOLOGICALAutologous Muscle Progenitor Cells
Autologous MPCs, administered via a single, direct injection into the bladder neck sphincter region
Sponsors
Wake Forest University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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 (e.g., oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy) * 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 (bilateral ectopic ureters with incompetent bladder neck; or female epispadias with or without bladder exstrophy) 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 (e.g. medically necessary, stable drugs) 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 at enrollment) * 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 with urinary incontinence other than the categories being investigated * Patients with significant (\>grade 2) pelvic organ prolapse (e.g., cystocele, rectocele) * Patients with vaginal prolapse beyond introitus * Patients with neurological disorders (e.g., multiple sclerosis, Parkinson's disease) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-related serious adverse events and the incidence of protocol defined treatment or procedure related adverse events | 12 months | the subject/biopsy/treatment site will be monitored for signs of bleeding, infection, continued pain, prolonged hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in Incontinence Assessment by pad test | baseline, 3, 6, and 12 months post-injection | Subjects will undergo 1 hour and 24 hour pad tests (pads are weighed)at baseline which are compared to the tests post-injection treatment |
| change in Number of incontinence episodes and pads used per day | baseline, 3, 6 and 12 months post-injection treatment | through Voiding diaries, the number of incontinence episodes and pads used per day are compared to baseline |
| change in Urogenital distress and quality of life | baseline, 3, 6 and 12 months post-injection treatment | subjects will complete the Urinary Incontinence and Quality of Life questionnaires and the baseline results will be compared to the 3, 6 and 12 months post injection results. |
Countries
United States
Outcome results
None listed