Evaluation of Enhanced Therapeutic Effect of Adipose Stromal Vascular Fraction Added With Human Platelet Lysate in Treatment of Osteoarthritis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 27
- 主要终点
- Expression of trophic-related genes in cartilage samples treated with SVF added or not with HPL
研究概览
简要总结
Osteoarthritis (OA) is a highly progressive and debilitating joint disease. Recently, it was demonstrated the existence of an important link between OA inflammation and progression of structural changes. Therapy with intra-articular injection of stromal vascular fraction (SVF) holds great promises and its efficacy could be further augmented with the addition of biological adjuvants. In the present project, we aim at demonstrating that human platelet lysate (HPL) increases the intrinsic beneficial properties of SVF on cartilage regeneration and joint environment. Moreover, we want to verify if SVF-conditioned medium (CM) obtained from SVF primed with HPL yields comparable or superior outcomes than whole SVF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •OA patients
- •Subscription of informed consent
- •BMI < 30
- •age between 55-75 years included
- •Kelgrenn-Lawrence equal or superior to grade III
- •presence of synovitis
- •patients undergoing knee replacement
- •suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice Healthy subjects from aesthetic plastic surgery
- •Subscription of informed consent
- •BMI < 30
- •age between 18-50 years included
- •subjects undergoing liposuction and/or abdominoplasty
排除标准
- •HCV, HIV, HBV, TPHA infection
- •Pregnancy (auto declaration)
结局指标
主要结局
Expression of trophic-related genes in cartilage samples treated with SVF added or not with HPL
时间窗: surgery as scheduled by clinic routine
With this project, we expect to demonstrate that HPL increases the beneficial properties of SVF on cartilage regeneration and joint environment. We envision that HPL will increase expression of genes involved in ECM synthesis, thus enhancing cartilage regeneration. Based on previous published data, we will consider as statistical a difference between treated (SVF + HPL) and not treated samples (SVF) of two folds in expression of genes involved in ECM production (e.g. COL2A1, ACAN, SOX9). A fold increase equal to 2 is the minimum value to consider biologically relevant the influence of the treatment compared to a control group in which the gene expression is considered to be equal to 1. If our hypothesis will be confirmed, this will allow to improve the current therapy for OA with a biological adjuvant that reduces disease progression and helps cartilage regeneration.
次要结局
未报告次要终点