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NCT03642054 Clinical Trial

Advanced Biomarker Assessment in Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:
Advanced Biomarker Assessment of Adipose Derived Stem Cells and Fibroblasts in Patients With and Without Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03642054
Other study ID # 17-009172
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 29, 2018
Est. completion date May 18, 2020

Study information
Verified date August 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date May 18, 2020
Est. primary completion date May 18, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Mayo Clinic in Arizona Phoenix Arizona

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Advanced biomarker assessments will include messenger RNA sequencing. 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). one year
Secondary 2. Assess 3-D Biomaterial nanoscaffolds as potential carriers of ASC's to treat prolapse. 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. 1.5 years
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