NCT02836145

Brief 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. 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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

July 14, 2016

Last Update Submit

July 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cell count

    Day 50

Interventions

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cell lines (human induced pluripotent stem cells, hiPSCs)

You may qualify if:

  • human induced pluripotent stem cells, hiPSCs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
National Taiwan University Hospital

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 18, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2017

Last Updated

July 18, 2016

Record last verified: 2016-07