- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01953315
Muscle Progenitor Cell Therapy for Urinary Incontinence (MPC)
February 28, 2024 updated by: Wake Forest University
A Phase 1 Pilot Safety and Feasibility Study of Muscle Progenitor Cell (MPC) Therapy for Urinary Incontinence
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Wake Forest Institute for Regenerative Medicine (WFIRM)
-
Winston-Salem, North Carolina, United States, 27103
- Wake Forest Urology Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Autologous Muscle Progenitor Cells
Autologous MPCs, administered via a single, direct injection into the bladder neck sphincter region
|
Autologous MPCs, administered via a single, direct injection into the bladder neck sphincter region
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of treatment-related serious adverse events and the incidence of protocol defined treatment or procedure related adverse events
Time Frame: 12 months
|
the subject/biopsy/treatment site will be monitored for signs of bleeding, infection, continued pain, prolonged hospitalization
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in Incontinence Assessment by pad test
Time Frame: 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
|
baseline, 3, 6, and 12 months post-injection
|
change in Number of incontinence episodes and pads used per day
Time Frame: 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
|
baseline, 3, 6 and 12 months post-injection treatment
|
change in Urogenital distress and quality of life
Time Frame: 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.
|
baseline, 3, 6 and 12 months post-injection treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gopal Badlani, MD, Wake Forest School of Medicine, Dept. of Urology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
January 1, 2018
Study Registration Dates
First Submitted
August 27, 2013
First Submitted That Met QC Criteria
September 25, 2013
First Posted (Estimated)
September 30, 2013
Study Record Updates
Last Update Posted (Actual)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Urologic Diseases
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urination Disorders
- Elimination Disorders
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Urinary Incontinence
- Enuresis
Other Study ID Numbers
- IRB00023616
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urinary Incontinence
-
University of New MexicoRecruitingUrinary Incontinence | Urge Incontinence | Stress Incontinence, FemaleUnited States
-
Juna d.o.o.CompletedFemale Stress Urinary Incontinence | Mixed Incontinence, Urge and Stress
-
University of California, San FranciscoNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Stanford...CompletedUrinary Incontinence, Stress | Urge Incontinence | Urinary Stress Incontinence | Stress Incontinence, Urinary | Stress Incontinence | Stress Incontinence, Female | Urgency UrinaryUnited States
-
Ludwig-Maximilians - University of MunichUnknownIncontinence, Overactive Bladder, Stress Urinary IncontinenceGermany
-
San Diego Sexual MedicineRecruitingStress Urinary Incontinence | Urge IncontinenceUnited States
-
Copenhagen University Hospital at HerlevZealand University HospitalTerminatedStress Urinary Incontinence | Urge Urinary IncontinenceDenmark
-
ScitonCompletedUrinary Incontinence | Stress Urinary Incontinence | Urge IncontinenceUnited States
-
Far Eastern Memorial HospitalRecruitingWomen With Stress Urinary IncontinenceTaiwan
-
Université de SherbrookeRecruitingUrinary Incontinence | Urinary Stress Incontinence | Post-Prostatectomy Incontinence | Stress Incontinence, MaleCanada
-
University of ZurichCompletedStress Urinary Incontinence | Urge Urinary Incontinence
Clinical Trials on Autologous Muscle Progenitor Cells
-
Zhejiang UniversityCompletedIdiopathic Pulmonary Arterial HypertensionChina
-
Zhejiang UniversityCompletedIdiopathic Pulmonary Arterial HypertensionChina
-
Zhejiang UniversityUnknownIdiopathic Pulmonary Arterial HypertensionChina
-
Johann Wolfgang Goethe University HospitalUniversity of LeipzigTerminatedCoronary Artery Disease | Acute Myocardial InfarctionGermany
-
Bioray LaboratoriesNanfang Hospital, Southern Medical UniversityNot yet recruitingSickle Cell Disease
-
Bioray LaboratoriesFirst Affiliated Hospital of Guangxi Medical UniversityNot yet recruiting
-
University of ZurichGCP-Service International Ltd. & Co. KGRecruitingFemale Stress Urinary IncontinenceSwitzerland
-
Jason GilleranCompletedUrinary Incontinence | Urinary RetentionUnited States
-
Cook MyoSiteCompleted
-
Southern Medical University, ChinaCellonis Biotechnology Co. Ltd.; The Second People's Hospital of Nanhai District... and other collaboratorsCompletedStroke | Infarction, Middle Cerebral ArteryChina