Advanced Biomarker Assessment in Pelvic Organ Prolapse

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic in Arizona

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

6 patients with pelvic organ prolapse and 6 patients without pelvic organ prolapse.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2018
• Primary Completion (ACTUAL): May 18, 2020
• Study Completion (ACTUAL): May 18, 2020

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (ACTUAL): August 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 17-009172

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No