NCT02698813Unknown1 期
Safety Study of Filler Agent Composed of Umbilical Cord Mesenchymal Stem Cells and Hyaluronic Acid
South China Research Center for Stem Cell and Regenerative Medicine0 个研究点目标入组 30 人开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 主要终点
- Proportion of patients with non-serious and serious adverse events
研究概览
简要总结
The overall goal of this study is to evaluate the safety and exploratory efficacy of the injectable filler agent composed of umbilical cord mesenchymal stem cells and hyaluronic acid for the improvement of wrinkles, acne, pitting scar and so on.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female over 18 years;
- •Have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures ;
- •Suitable for the medical history and physical examination like the following preoperative laboratory tests results: complete blood count, coagulation, biochemistry, electrocardiogram, hepatogram and β-human chorionic gonadotropin (hCG) for women of childbearing age.
排除标准
- •Patients unable to undergo surgery liposuction with Klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy;
- •Have history or active dermal diseases, inflammation, or any related disease;
- •Had invasive aesthetic treatments or surgeries history 6 months before the treatments;
- •Had physical or chemical aesthetic treatments 1 months before the study starts;
- •Have a known history of allergic reactions like hypersensitivity to hyaluronic acid;
- •Patients with limited understanding of the procedure or have poor compliance with the study or follow-up schedule;
- •Pregnant or lactating;
- •Use of drugs;
- •Patients with preoperative results considered inadequate.
研究组 & 干预措施
UCMSCs-HA
Experimental
Multipoint of Transdermal injection into the wrinkles. Injectable filler agent composed of umbilical cord mesenchymal stem cells (UCMSCs) and hyaluronic acid (HA).
干预措施: umbilical cord mesenchymal stem cells and hyaluronic acid (Biological)
Control
Active Comparator
Procedure: Transdermal injection of hyaluronic acid only.
干预措施: hyaluronic acid (Drug)
结局指标
主要结局
Proportion of patients with non-serious and serious adverse events
时间窗: Change from baseline up to week 12 after injection.
次要结局
- Global Aesthetic Improvement Scale (GAIS) Evaluation(Change from baseline at week 2, 6 and 12.)
- Wrinkle Severity Rating Scale (WSRS) Evaluation(Change from baseline at week 2, 6 and 12.)
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