NCT01828723已完成1 期
A Phase One, Open Label, Single Arm Study to Demonstrate the Safety of Antria Cell Preparation Process During Facial Fat Grafting Assisted With Autologous, Adipose Derived Stromal Vascular Fraction (SVF)
Antria2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2013年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- To evaluate the safety of the administration of a concentrated SVF-enriched fat graft by monitoring the number and types of adverse events, and via physical examinations, vital signs, 12-lead ECGs, blood draws (CBC/LFT/BMP), and urinalysis.
研究概览
简要总结
The primary purpose of this study is to demonstrate the safety of injecting the Stromal Vascular Fraction (SVF) [containing Adipose Derived Stem Cells (ADSCs)] enriched fat grafts into regions of the face that require enhancement. The safety of SVF will be evaluated throughout the course of the study phase through the assessment of laboratory values, physical examinations, adverse events, safety phone calls etc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or Male, Age 18 years or older
- •Subjects that are scheduled for liposuction and facial fat grafting procedures for cosmetic purposes
- •Facial volume defects which could be treated with a total graft volume of between 1mL and 50mL
- •BMI between and including 23 and 28
- •Able to understand and provide written and verbal informed consent
排除标准
- •Currently taking or have taken NSAIDs within last two weeks or corticosteroids within the last six weeks prior to screening
- •Diagnosis of any of the following medical conditions:
- •Active malignancy (diagnosed within 5 years), except for treated non-melanoma skin cancer or other non-invasive or in-situ neoplasm
- •Active infection
- •Type I or Type II Diabetes
- •Subjects who are unlikely to comply with the protocol (e.g., uncooperative attitude, inability to return for subsequent visits, dementia, and/or otherwise considered by the Investigator to be unlikely to complete the study)
- •Subjects with a known drug or alcohol dependence within the past 12 months as judged by the Investigator
- •Subjects with major illnesses involving the renal, hepatic, cardiovascular, and/or nervous systems
- •Subjects with elevated kidney and/or liver functions
- •Any other disease condition or laboratory results that in the opinion of the investigator may be clinically significant and render the subject inappropriate for the study procedure(s), may alter the accuracy of study results, or increase risk for subjects.
- •Subjects with life-expectancies less than 9 months
- •Subjects with known collagenase allergies
- •Subjects with idiopathic or drug-induced coagulopathy
- •Pregnant females
- •On radiotherapy or chemotherapy agents
- •Taking strong CYP450 inhibitors such as protease inhibitors (ritonavir, indinavir, nelfinavir, saquinavir), macrolide antibiotics (clarithromycin, telithromycin), chloramphenicol, azole antibiotics (ketoconazole, itraconazole) and nefazodone.
- •Subjects with a history of keloids or hypertrophic scar formations
结局指标
主要结局
To evaluate the safety of the administration of a concentrated SVF-enriched fat graft by monitoring the number and types of adverse events, and via physical examinations, vital signs, 12-lead ECGs, blood draws (CBC/LFT/BMP), and urinalysis.
时间窗: 6 months
次要结局
- To demonstrate the efficacy of the addition of autologous SVF isolated via Antria Cell Preparation Process by observing graft survival time, volume, and quality of facial re-contouring(6 months)
研究者
研究点 (2)
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