PLLA-ADIPOGENESIS-IFA: Immunofluorescence Analysis to Quantify Changes Induced by Poly-L-Lactic Acid in Adipose Tissue
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Change in cell count per area between PLLA and saline-treated specimens.
Study Overview
Brief Summary
Primary Objective: use immunofluorescence (IF) on previously obtained biopsies to analyze and quantify changes in adipose tissue of subjects injected with poly-L-lactic acid (PLLA) or saline.
Detailed Description
Sixteen female adults that participated in SPLASH study will be enrolled in this retrospective study. It aims to analyze previously collected biopsy samples from participants who completed the "SPLASH: Split-Body Randomized Clinical Trial of Poly-L-Lactic Acid for Adipogenesis and Volumization of the Hip Dell" study. The study will use immunohistology to assess changes in adipose tissue associated with treatment with PLLA (poly-L-lactic acid). We hypothesize that specimens treated with PLLA will be found to have more adipocyte-derived stem cells and preadipocytes undergoing mitosis and differentiation compared to control specimens.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects who completed all biopsies in the previous SPLASH trial "A Single Center, Double- Blinded, Split-Body, Randomized Clinical Trial of Injectable Poly-L-Lactic Acid for Volumization and Adipogenesis of the Hip Dell - Protocol Number Sculptra-Hip-Dell-2021-12" .
Exclusion Criteria
- •Subjects who had biopsies of poor quality, insufficient tissue, or were otherwise unsuitable for immunofluorescence analysis.
Outcomes
Primary Outcomes
Change in cell count per area between PLLA and saline-treated specimens.
Time Frame: Specimens are from 6 months post-treatment compared to pre-treatment / Baseline
Analyzing between PLLA and saline-treated specimens for the following populations: * adipocyte derived stem cells * proliferating adipocyte-derived stem cells * preadipocytes/adipocyte precursors * proliferating preadipocytes/adipocyte precursors * mature adipocytes and actively differentiating precursors The following proteins will be quantified and the differences between PLLA and saline-treated specimens at 6 months compared to pre-treatment will also be analyzed: * β-catenin * PPARγ * Adiponectin * Perilipin-1
Secondary Outcomes
No secondary outcomes reported