Immunophenotyping of Fresh Stromal Vascular Fraction From Adipose Derived Stem Cells (ADSC) Enriched Fat Grafts for Refinements of Reconstructed Breasts
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Volume Maintenance
研究概览
简要总结
The purpose of this study is to investigate if there is a relationship between the take of fat grafts with and without ADSCs and the presence of specific surface markers on the cells of the stromal vascular fraction.
详细描述
Two groups of patients will be studied. The control will receive centrifuged fat grafts while the other group will receive centrifuged enriched fat grafts with ADSCs. The performance of both grafts will be assessed through volume measurement employing MRI before and after 6 months post-op.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •contour irregularities and volume insufficiency in reconstructed breasts no matter the method of reconstruction employed
- •local flaps with conditions to receive fat grafts
- •good health condition
排除标准
- •breast cancer patients under chemotherapy
- •bad health condition
- •patients too thin
- •patients that require a new reconstructive surgery (secondary reconstruction)
研究组 & 干预措施
centrifuged fat graft
female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.
干预措施: centrifuged fat graft (Genetic)
ADSCs enriched centrifuged fat graft
female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement
干预措施: ADSCs enriched fat graft (Genetic)
结局指标
主要结局
Volume Maintenance
时间窗: up to 1 year
Volumetry of the reconstructed breasts will be accomplished through MRI and OsiriX software. Osirix software allows breast volume calculation through the determination of regions of interest (ROIs) on an MRI sequence. Once the pre (V1) and postoperative (V2) volumes were determined the following formula was applied: (V2 - V1) X 100/graft volume. The result, expressed in percentage, expresses graft volume persistence.
次要结局
- Immunophenotyping(baseline)
研究者
Luiz Alexandre Lorico Tissiani
MD, Chief of Breast Reconstructive Unit at Hospital Municipal Carmino Caricchio
University of Sao Paulo