Urinary Stress IncontinencePhase 1MUSICNCT03439527
Multisystem Cell Therapy for Improvement of Urinary Continence
A Phase 1 study testing Muscle Precursor Cells (MPCs), ATMP in people with Urinary Stress Incontinence, run by University of Zurich at 1 site in Switzerland.
Trial summary
The rising success of cell therapies places an increasing burden on health care costs. Consequently, the need to reduce production costs while maintaining quality has been widely acknowledged. In addition, the demand for high-quality products with an optimal safety profile is increasing. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Urinary Stress Incontinence
- What is being tested?
- Muscle Precursor Cells (MPCs), ATMP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Jan 2020to 21 Oct 2021
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult women 20y-60y
- Incontinence >/= grade I since at least 6 months
- Predominant clinical diagnosis of SUI
- Candidate for a surgical treatment (artificial urinary sphincter, synthetic compressive tapes or adjustable balloons).
- Post void residual volume of <100 ml (exclusion of overflow incontinence)
- Can independently use toilet without difficulty
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- Capacity to answer the questionnaires of evaluation
- Negative blood test for: Human immunodeficiency virus (HIV 1/2), Hepatitis B HBsAg, Anti HBc, Hepatitis C Anti-HCV-Ab, Syphilis
- Competent to comprehend, sign and date informed consent form before any study-specific procedure is performed
Who cannot join
- History of anti-incontinence or prolapse surgery.
- Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract:
- Clinically significant cystocele or rectocele
- Ureteric bladder, urethral or rectal fistula
- Uncorrected congenital abnormality leading to urinary incontinence
- Interstitial cystitis
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- Urinary urgency that results in leakage (as a predominant symptom)
- Adult enuresis
- Urodynamically proven detrusor instability
- Sensory urgency defined as first sensation of bladder fill (urge to void) of <100 ml; bladder capacity of <300 ml
- No sensation at any time during the simple filling cystometry procedure
- Known urethral stenosis (ureterocystoscopy) or urethral diverticulum
- History of urogenital cancer or history of pelvic radiotherapy
- Women who are pregnant, breast feeding or <12 months postpartum Note: Female subjects who are surgically sterilized, hysterectomized or post-menopausal for longer than 2 years are not considered as having child bearing potential. No pregnancy test will be performed for this population.
- Untreated symptomatic urinary tract infection
- Fever (as defined by ≥ 38,5°C, axillar measurement), any infectious disease, cold or flu within the last 7 days
- Unstable severe systemic disease including uncontrolled hypertension, unstable angina, or myocardial infarction, severe coagulation disorders, bleeding diathesis, emboli, thrombophlebitis, infectious diseases, poor wound healing, and poorly controlled diabetes mellitus within 6 months before enrolment
- Any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results.
- Known allergy or intolerance of at least one of the active ingredients or excipients of the investigational products
- Known allergy or intolerance of Penicillin or Streptomycin
- Known genetically determined or acquired muscular disease.
- Known Neurological disorder (Parkinson's disease, multiple sclerosis, spina bifida, medullary traumatism).
- Medication regimen including estrogens, anti-estrogens or diuretics where dose and/or frequency has not been stable for at least the past 12 weeks or is anticipated to change during the course of the study.
- Chronic use of any of the following drugs and not stopped for at least 2 weeks prior to inclusion into the study: selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI), alpha-receptor antagonists/agonists, beta-3-receptor agonists or anticholinergic/-muscarinic drugs.
- Chronic use of any of the following drugs and not stopped for at least 6 months prior to inclusion into the study: Antidepressants or neuroleptic drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Monocentric, First-in-man Trial to Assess Safety and Tolerability of a New Therapeutic Strategy for Stress Urinary Incontinence Based on the Implantation of Muscle Precursor Cells (MPCs)
The rising success of cell therapies places an increasing burden on health care costs. Consequently, the need to reduce production costs while maintaining quality has been widely acknowledged. In addition, the demand for high-quality products with an optimal safety profile is increasing. The proposed cell treatment is the first therapeutical option with the possibility to revert the underlying condition. The investigators expect that this healing response will be achieved with minimal side effects justifying the addional costs and complexity.
Read the detailed description
muscle precursor cells (MPCs) will be isolated from biopsies of the lower leg of patients, seeded, expanded and cultivated in vitro in a GMP facility to generate vital muscle cells dedicated for implantation.
These muscle cells exhibit myogenic phenotype (IHC and flow cytometry) and therefore morphological and histological prerequisites approximating the properties of native skeletal muscle tissue. The muscle progenitor cells shall be applied in external sphincter muscle for the treatment of patients with stress urinary incontinence.
- Conditions
- Urinary Stress Incontinence
- Being tested
- Muscle Precursor Cells (MPCs), ATMP
- Keywords
- Muscle Precursor Cells
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Precursor Cells (MPCs), ATMPOther
The advanced therapeutic investigational product, the MPCs, is a living, autologous cell-product isolated from a biopsy of the patient's own musculus soleus.
| Study group | Role | What they receive |
|---|---|---|
| MPC-group | Experimental | All patients are treated by the same product: Autologous MPCs Receives: Other: Muscle Precursor Cells (MPCs), ATMP |
| NMES+MPC-group | Other | After treatment, the patients will be randomized 1:1 in the MPC-group or NMES+MPC-group to investigate the benefits of an additional physiotherapy (Neuromuscular Electromagnetic Stimulation, NMES) Receives: Other: Muscle Precursor Cells (MPCs), ATMP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically relevant Adverse Events of MPCs or related to cell injection
Number of clinically relevant findings related to cell injection
Measured: at 3 months post-implantation
Secondary outcomes (12)
Feasibility of MPC injection
Percentage of subjects with successful injection
Measured: day of implantation
Efficacy of MPC injection measured by post-void residual volume
post-void residual volume
Measured: at baseline, day of implantation, 1 month, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Uroflowmetry
Uroflowmetry: urinary flow pattern
Measured: at baseline, day of implantation, 1 month, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Urodynamic Evaluation
2 Filling-Cystometries
Measured: at baseline, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Urodynamic Evaluation
2 Pressure-Flow studies
Measured: at baseline, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Urodynamic Evaluation
Urethal-Pressure-Profile
Measured: at baseline, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by 1h pad test
1h pad test
Measured: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy measured by average Incontinence Score
Incontinence Score. Range from 0 (no incentinence) to 21 (highly incontinent)
Measured: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy measured by average score of Visual Analog Scale of degree of suffering
Visual Analog Scale of degree of suffering. Range 0 (worst) to 10 (best)
Measured: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy measured by average score of Quality of Life
Quality of Life Score, using SF-36v2™ Health Survey
Measured: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy
Number for (planned) subsequent incontinence surgery
Measured: 6 months post-implantation
Number of patients with abnormal laboratory values and/or Adverse Events that are related to MPC injection
Safety measures (ultrasound, physical examination, laboratroy)
Measured: at baseline, day of implantation, 1 month, 3 months and 6 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start22 Jan 2020
- Primary completion3 Sep 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Stress 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open-label, monocentric, first-in-man trial to assess safety and tolerability of a new therapeutic strategy for stress urinary incontinence based on the implantation of muscle precursor cells (MPCs) 40 female patients suffering from urinary incontinence since at least 6 months (predominant clinical diagnosis of SUI) and who are candidate for a surgical treatment will be included . All patients are treated by the same product: Autologous MPCs. After treatment, the patients will be randomized 1:1 in the MPC-group or NMES+MPC-group to investigate the benefits of an additional physiotherapy.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Tuebingen, Salzburger Landeskliniken
- Responsible party
- Sponsor
- Investigators
- Daniel Eberli, Prof, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439527
- Sponsor's protocol ID
- H2020-SC1-2016-2017
- Other IDs
- 731377
- Acronym
- MUSIC
- Status last verified
- Oct 2021
- First submitted
- 18 Dec 2017
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Monocentric, First-in-man Trial to Assess Safety and Tolerability of a New Therapeutic Strategy for Stress Urinary Incontinence Based on the Implantation of Muscle Precursor Cells (MPCs)
- ClinicalTrials.gov ID
- NCT03439527
- Acronym / sponsor ID
- MUSIC / H2020-SC1-2016-2017
- Conditions
- Urinary Stress Incontinence
- Keywords
- Muscle Precursor Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital Tuebingen, Salzburger Landeskliniken
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 3 Sep 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 20 Feb 2018 (actual)
- 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.
The rising success of cell therapies places an increasing burden on health care costs. Consequently, the need to reduce production costs while maintaining quality has been widely acknowledged. In addition, the demand for high-quality products with an optimal safety profile is increasing. The proposed cell treatment is the first therapeutical option with the possibility to revert the underlying condition. The investigators expect that this healing response will be achieved with minimal side effects justifying the addional costs and complexity.
Detailed description
muscle precursor cells (MPCs) will be isolated from biopsies of the lower leg of patients, seeded, expanded and cultivated in vitro in a GMP facility to generate vital muscle cells dedicated for implantation.
These muscle cells exhibit myogenic phenotype (IHC and flow cytometry) and therefore morphological and histological prerequisites approximating the properties of native skeletal muscle tissue. The muscle progenitor cells shall be applied in external sphincter muscle for the treatment of patients with stress urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, monocentric, first-in-man trial to assess safety and tolerability of a new therapeutic strategy for stress urinary incontinence based on the implantation of muscle precursor cells (MPCs) 40 female patients suffering from urinary incontinence since at least 6 months (predominant clinical diagnosis of SUI) and who are candidate for a surgical treatment will be included . All patients are treated by the same product: Autologous MPCs. After treatment, the patients will be randomized 1:1 in the MPC-group or NMES+MPC-group to investigate the benefits of an additional physiotherapy.
| Arm | Type | Receives |
|---|---|---|
| MPC-group | Experimental | Other: Muscle Precursor Cells (MPCs), ATMPAll patients are treated by the same product: Autologous MPCs |
| NMES+MPC-group | Other | Other: Muscle Precursor Cells (MPCs), ATMPAfter treatment, the patients will be randomized 1:1 in the MPC-group or NMES+MPC-group to investigate the benefits of an additional physiotherapy (Neuromuscular Electromagnetic Stimulation, NMES) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adult women 20y-60y
- Incontinence >/= grade I since at least 6 months
- Predominant clinical diagnosis of SUI
- Candidate for a surgical treatment (artificial urinary sphincter, synthetic compressive tapes or adjustable balloons).
- Post void residual volume of <100 ml (exclusion of overflow incontinence)
Key exclusion criteria (25 listed)
- History of anti-incontinence or prolapse surgery.
- Previous diagnosis of any of the following conditions, disorders, or diseases of the urinary tract:
- Urinary urgency that results in leakage (as a predominant symptom)
- Adult enuresis
- Urodynamically proven detrusor instability
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 |
|---|---|---|
| Muscle Precursor Cells (MPCs), ATMPThe advanced therapeutic investigational product, the MPCs, is a living, autologous cell-product isolated from a biopsy of the patient's own musculus soleus. | Other | MPC-group, NMES+MPC-group |
Primary outcome
Incidence of clinically relevant Adverse Events of MPCs or related to cell injection
Time frame: at 3 months post-implantation
Number of clinically relevant findings related to cell injection
12 secondary outcomes
Feasibility of MPC injection
Time frame: day of implantation
Efficacy of MPC injection measured by post-void residual volume
Time frame: at baseline, day of implantation, 1 month, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Uroflowmetry
Time frame: at baseline, day of implantation, 1 month, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Urodynamic Evaluation
Time frame: at baseline, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Urodynamic Evaluation
Time frame: at baseline, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by Urodynamic Evaluation
Time frame: at baseline, 3 months and 6 months post-implantation
Efficacy of MPC injection measured by 1h pad test
Time frame: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy measured by average Incontinence Score
Time frame: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy measured by average score of Visual Analog Scale of degree of suffering
Time frame: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy measured by average score of Quality of Life
Time frame: at baseline, 1 month, 3 months and 6 months post-implantation
Efficacy
Time frame: 6 months post-implantation
Number of patients with abnormal laboratory values and/or Adverse Events that are related to MPC injection
Time frame: at baseline, day of implantation, 1 month, 3 months and 6 months post-implantation
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 3 Nov 2021.
- 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.
Daniel Eberli, Prof principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Muscle Precursor Cells (MPCs), ATMP in people with Urinary Stress Incontinence, run by University of Zurich at 1 site in Switzerland.
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 9 inclusion and 25 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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 clinically relevant Adverse Events of MPCs or related to cell injection (time frame: at 3 months post-implantation). 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 3 Nov 2021; AzTrials last refreshed its copy on 31 Oct 2026.