A Proof of Concept Study to Demonstrate the Effectiveness of Antria Cell Preparation Process (Ace Process) in Extraction of Stromal Vascular Fraction From Adipose Tissue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 4
- 主要终点
- • To assess the success rate of our methodology in extraction of SVF from adipose tissue by performing cell count, cell viability tests and specific surface markers
研究概览
简要总结
Human Adipose Tissue is considered as a new source for Stromal Stem Cells and offers a large therapeutic potential for many rare and common diseases that impacts millions of patients worldwide. The Stromal Vascular Fraction (SVF) of Adipose Tissue is relatively easy to extract with minimally invasive procedures such as elective liposuction in large quantities and therefore may be a cost effective source for cellular therapies in a wide range of medical specialties. In this study we aim to demonstrate the efficacy of Antria Cell Preparation Process© in obtaining human adipose derived Stromal Vascular Fraction (SVF) by performing histology, various cell counts, multiple surface marker tests and measurement of the residual amount of digestive enzymes as a safety measure for human clinical trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female Age: 18 - 65 Scheduled for Liposuction Procedure Able to understand and provide written informed Consent
排除标准
- •Diagnosis of any of the following medical conditions:
- •Active malignancy (diagnosed within 5 years) except for adequately treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm (e.g. cervical cancer) Active Infection Chronic use of NSAID's or Steroids On Radiotherapy or Chemotherapy agents Any other disease or condition that may alter the accuracy of study results (e.g. Severe Osteoporosis, Rheumatoid Arthritis and other autoimmune disorders)
结局指标
主要结局
• To assess the success rate of our methodology in extraction of SVF from adipose tissue by performing cell count, cell viability tests and specific surface markers
时间窗: one month
次要结局
- To compare the effectiveness of 2 different digestive enzymes in randomly selected set of samples(one month)
- To measure the amount of residual digestive enzyme after the procedure(one month)
- To determine the time and cost of supply during the procedure(one month)
- To conclude logistic barriers (transport and testing of cells)(one month)
- Obtaining cultures to detect potential contamination by pathogenes(one month)