Muscle Progenitor Cell Therapy for Urinary Incontinence

NCT ID: NCT01953315

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous Muscle Progenitor Cells

Autologous MPCs, administered via a single, direct injection into the bladder neck sphincter region

Group Type: EXPERIMENTAL

Autologous Muscle Progenitor Cells

Intervention Type: BIOLOGICAL

Autologous MPCs, administered via a single, direct injection into the bladder neck sphincter region

Interventions

Autologous Muscle Progenitor Cells

Autologous MPCs, administered via a single, direct injection into the bladder neck sphincter region

Intervention Type: BIOLOGICAL

Other Intervention Names

MPCs

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gopal Badlani, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest School of Medicine, Dept. of Urology

Locations

Wake Forest Urology Clinic

Winston-Salem, North Carolina, United States

Wake Forest Institute for Regenerative Medicine (WFIRM)

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00023616

Identifier Type: -

Identifier Source: org_study_id