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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03642054
Enrollment
18
Registered
2018-08-22
Start date
2018-06-29
Completion date
2020-05-18
Last updated
2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse

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.

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.

Interventions

None listed

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Advanced biomarker assessments will include messenger RNA sequencing.one yearRNA-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

MeasureTime frameDescription
2. Assess 3-D Biomaterial nanoscaffolds as potential carriers of ASC's to treat prolapse.1.5 yearsmRNA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026