Muscle Progenitor Cell Therapy for Urinary Incontinence

NCT01953315 | Completed Phase 1 DMC

• 1 other identifier: IRB00023616
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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).

Conditions

Urinary Incontinence

Keywords

urinary incontinence, muscle progenitor cells, MPCs

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-related serious adverse events and the incidence of protocol defined treatment or procedure related adverse events

  the subject/biopsy/treatment site will be monitored for signs of bleeding, infection, continued pain, prolonged hospitalization

  12 months

Secondary Outcomes (3)

• change in Incontinence Assessment by pad test

  baseline, 3, 6, and 12 months post-injection

• change in Number of incontinence episodes and pads used per day

  baseline, 3, 6 and 12 months post-injection treatment

• change in Urogenital distress and quality of life

  baseline, 3, 6 and 12 months post-injection treatment

Study Arms (1)

Autologous Muscle Progenitor Cells

EXPERIMENTAL

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

Biological: Autologous Muscle Progenitor Cells

Interventions

Autologous Muscle Progenitor Cells BIOLOGICAL

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

Also known as: MPCs

Autologous Muscle Progenitor Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (2)

Wake Forest Urology Clinic

Winston-Salem, North Carolina, 27103, United States

Location

Wake Forest Institute for Regenerative Medicine (WFIRM)

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gopal Badlani, MD

  Wake Forest School of Medicine, Dept. of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2013
• First Posted: September 30, 2013
• Study Start: January 1, 2014
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 1, 2024

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)