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Advanced Biomarker Assessment in Pelvic Organ Prolapse

Sponsor
Mayo Clinic (Other)
Overall Status
Completed
CT.gov ID
NCT03642054
Collaborator
(none)
18
Enrollment
1
Location
22.6
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess advanced biomarkers in patients with and without vaginal prolapse. Assessments will be directed at vaginal fibroblasts and adipose derived stem cells.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Vaginal biopsies and abdominal adipose harvest will be accomplished in patients undergoing vaginal hysterectomy for non-prolapse benign conditions (6) and pelvic organ prolapse (6). Samples of tissues will be divided and portions will be snap-frozen, placed into transport medium for subsequent tissue digestion, and receive paraffin processing. Cells in transport medium will be transported to the Mayo Collaborative Research building (lab of Dr. David Lott) for isolation of fibroblasts and adipose derived stem cells.

    The other samples will be transported to the lab of Dr. Andre van Wijnen (RST) to isolate RNA and protein for mRNA, microRNA and additional protein analysis.

    Isolated fibroblasts and ASC's from the lab of Dr. Lott (MCA) will be expanded and passaged 3-5 times. ASCs phenotype will be confirmed by flow cytometry. Cells lines will be duplicated and biobanked at the Mayo Clinic Rochester Biotrust and separately biobanked at the Arizona State University lab of scaffold collaborator, Dr. Stephen Massia. Additional frozen cell lines will transported to the lab of Dr. Andre van Wijnen for further processing. . All cells and materials will be used for testing and to advance the science of regenerative medicine. No biobanked cells or materials from this specific project will be used for any future intervention or treatment in humans.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    18 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Advanced Biomarker Assessment of Adipose Derived Stem Cells and Fibroblasts in Patients With and Without Pelvic Organ Prolapse
    Actual Study Start Date :
    Jun 29, 2018
    Actual Primary Completion Date :
    May 18, 2020
    Actual Study Completion Date :
    May 18, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Pelvic Organ Prolapse

    Patients having vaginal hysterectomy who demonstrate grade III-IV uterovaginal prolapse.
    Non Pelvic Organ Prolapse

    Patients having vaginal hysterectomy who do not demonstrate uterovaginal prolapse.

    Outcome Measures

    Primary Outcome Measures

    1. Advanced biomarker assessments will include messenger RNA sequencing. [one year]

      RNA-Seq will determine if there are differences in mRNA or exon expression between cells from prolapse and normal patients, with focus on genes involved in connective tissue metabolism (e.g., collagens, MMPs, TIMPs, myofibroblast markers).

    Secondary Outcome Measures

    1. 2. Assess 3-D Biomaterial nanoscaffolds as potential carriers of ASC's to treat prolapse. [1.5 years]

      mRNA levels of ASC's in normal and prolapse patients will be assessed as markers for successful cell seeding on 3D-biomaterial nanoscaffolds and compared to cells under standard 2D-cell culture conditions that are used to generate clinical grade ASC's.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria-

    • Patients undergoing vaginal hysterectomy for non-prolapse benign conditions and pelvic organ prolapse

    • at least 18 years old

    • Mayo Clinic patient

    Exclusion Criteria-

    °Patients who have a history of a recognized classic connective tissue disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Arizona Phoenix Arizona United States 85054

    Sponsors and Collaborators

    • Mayo Clinic

    Investigators

    • Principal Investigator: Johnny Yi, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Johnny Yi, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT03642054
    Other Study ID Numbers:
    • 17-009172
    First Posted:
    Aug 22, 2018
    Last Update Posted:
    Sep 24, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prolapse
    Pelvic Organ Prolapse

    Study Results

    No Results Posted as of Sep 24, 2021