Female Urinary Incontinence and Pelvic Organ ProlapseNCT02836145
Biomolecular Messages Associated With the Differentiation of Human Induced Pluripotent Stem Cells to Skeletal Muscle Progenitor Cells
An observational study of Female Urinary Incontinence and Pelvic Organ Prolapse, run by National Taiwan University Hospital.
Trial summary
Female urinary incontinence and pelvic organ prolapse are common diseases especially in aged women that frequently cause urogenital infection, voiding difficulty, urinary retention, pelvic pain, constipation, and coital difficulty, as well as impact the quality of life of women. Read more about this study
- Who is it for?
- Ages 20 to 80 years, women only
- Conditions the study is for
- Female Urinary Incontinence and Pelvic Organ Prolapse
- What is being tested?
- Differentiation of hiPSCs to skeletal muscle progenitors
- How many people
- 6 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Jul 2017
- Phase
- Observational
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Cell lines (human induced pluripotent stem cells, hiPSCs)
Who may be able to join
- human induced pluripotent stem cells, hiPSCs
Who cannot join
- -
About this study
Female urinary incontinence and pelvic organ prolapse are common diseases especially in aged women that frequently cause urogenital infection, voiding difficulty, urinary retention, pelvic pain, constipation, and coital difficulty, as well as impact the quality of life of women. Risk factors of the above diseases include pregnancy, vaginal delivery, and menopausal status. Despite playing a crucial role in the pathophysiology of the above diseases, the urogenital skeletal muscular dysfunction cannot be fully corrected via the current treatment modalities.
The human induced pluripotent stem cells (hiPSCs) represent a prime candidate cell type for current research and future cell therapy because of their significant self-renewal, differentiation potential and the relative lack of ethical conflict. With the advent of efficient technology of reprogramming peripheral blood mononuclear cells (PBMCs) into hiPSCs, researchers can generate personalized lines of cells from which it will be possible to obtain differentiated cells in a less invasive way, introducing opportunities in treating diseases that are now considered incurable.
Until very recently, little success has been achieved in terms of skeletal muscle differentiation from hiPSCs. The purpose of this study is to explore the applicability of the differentiation into skeletal muscle progenitor cells from hiPSC cell lines and the associated biomolecular messages. It is anticipated that the derived skeletal muscle progenitor cells can be reprogrammed from PBMCs of female patients with urinary incontinence and/or pelvic organ prolapse and used in preclinical testing for relieving female urogenital problems.
- Being tested
- Differentiation of hiPSCs to skeletal muscle progenitors
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Differentiation of hiPSCs to skeletal muscle progenitorsOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell count
Measured: Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Urinary Incontinence and Pelvic Organ ProlapseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836145
- Sponsor's protocol ID
- NTU-REC-201603059RINA
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomolecular Messages Associated With the Differentiation of Human Induced Pluripotent Stem Cells to Skeletal Muscle Progenitor Cells
- ClinicalTrials.gov ID
- NCT02836145
- Acronym / sponsor ID
- NTU-REC-201603059RINA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jul 2017 (estimated)
- First posted
- 18 Jul 2016 (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.
Female urinary incontinence and pelvic organ prolapse are common diseases especially in aged women that frequently cause urogenital infection, voiding difficulty, urinary retention, pelvic pain, constipation, and coital difficulty, as well as impact the quality of life of women. Risk factors of the above diseases include pregnancy, vaginal delivery, and menopausal status. Despite playing a crucial role in the pathophysiology of the above diseases, the urogenital skeletal muscular dysfunction cannot be fully corrected via the current treatment modalities.
The human induced pluripotent stem cells (hiPSCs) represent a prime candidate cell type for current research and future cell therapy because of their significant self-renewal, differentiation potential and the relative lack of ethical conflict. With the advent of efficient technology of reprogramming peripheral blood mononuclear cells (PBMCs) into hiPSCs, researchers can generate personalized lines of cells from which it will be possible to obtain differentiated cells in a less invasive way, introducing opportunities in treating diseases that are now considered incurable.
Until very recently, little success has been achieved in terms of skeletal muscle differentiation from hiPSCs. The purpose of this study is to explore the applicability of the differentiation into skeletal muscle progenitor cells from hiPSC cell lines and the associated biomolecular messages. It is anticipated that the derived skeletal muscle progenitor cells can be reprogrammed from PBMCs of female patients with urinary incontinence and/or pelvic organ prolapse and used in preclinical testing for relieving female urogenital problems.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cell lines (human induced pluripotent stem cells, hiPSCs)
Key inclusion criteria (1 listed)
- human induced pluripotent stem cells, hiPSCs
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Differentiation of hiPSCs to skeletal muscle progenitors | Other | – |
Primary outcome
Cell count
Time frame: Day 50
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Urinary Incontinence and Pelvic Organ Prolapse, run by National Taiwan University Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
Cell count (time frame: Day 50). 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 18 Jul 2016; AzTrials last refreshed its copy on 7 Nov 2026.