Urinary IncontinencePhase 1MPCNCT01953315
Muscle Progenitor Cell Therapy for Urinary Incontinence
A Phase 1 study testing Autologous Muscle Progenitor Cells in people with Urinary Incontinence, run by Wake Forest University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Autologous Muscle Progenitor Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2014to Jan 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wake Forest Urology Clinic
Winston-Salem, North Carolina, 27103
Wake Forest Institute for Regenerative Medicine (WFIRM)
Winston-Salem, North Carolina, 27157
About this study
Official title: 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).
Read the 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
- Being tested
- Autologous Muscle Progenitor Cells
- Keywords
- urinary incontinence, muscle progenitor cells, MPCs
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Muscle Progenitor CellsBiological
Also called MPCs
Autologous MPCs, administered via a single, direct injection into the bladder neck sphincter region
| Study group | Role | What they receive |
|---|---|---|
| Autologous Muscle Progenitor Cells | Experimental | Autologous MPCs, administered via a single, direct injection into the bladder neck sphincter region Receives: Biological: Autologous Muscle Progenitor Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (3)
change in Incontinence Assessment by pad test
Subjects will undergo 1 hour and 24 hour pad tests (pads are weighed)at baseline which are compared to the tests post-injection treatment
Measured: baseline, 3, 6, and 12 months post-injection
change in Number of incontinence episodes and pads used per day
through Voiding diaries, the number of incontinence episodes and pads used per day are compared to baseline
Measured: baseline, 3, 6 and 12 months post-injection treatment
change in Urogenital distress and quality of life
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.
Measured: baseline, 3, 6 and 12 months post-injection treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gopal Badlani, MD, Principal investigator, Wake Forest School of Medicine, Dept. of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01953315
- Sponsor's protocol ID
- IRB00023616
- Acronym
- MPC
- Status last verified
- Jan 2018
- First submitted
- 27 Aug 2013
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Pilot Safety and Feasibility Study of Muscle Progenitor Cell (MPC) Therapy for Urinary Incontinence
- ClinicalTrials.gov ID
- NCT01953315
- Acronym / sponsor ID
- MPC / IRB00023616
- Conditions
- Urinary Incontinence
- Keywords
- urinary incontinence, muscle progenitor cells, MPCs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Muscle Progenitor Cells | Experimental | Biological: Autologous Muscle Progenitor CellsAutologous MPCs, administered via a single, direct injection into the bladder neck sphincter region |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Muscle Progenitor CellsAlso: MPCsAutologous MPCs, administered via a single, direct injection into the bladder neck sphincter region | Biological | Autologous Muscle Progenitor Cells |
Primary outcome
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
3 secondary outcomes
change in Incontinence Assessment by pad test
Time frame: 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
change in Urogenital distress and quality of life
Time frame: baseline, 3, 6 and 12 months post-injection treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gopal Badlani, MD principal investigator
Wake Forest School of Medicine, Dept. of Urology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Muscle Progenitor Cells in people with Urinary Incontinence, run by Wake Forest University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-related serious adverse events and the incidence of protocol defined treatment or procedure related adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.