Autologous Transplantation of Cultured Fibroblast for Correction of Nasolabial Folds
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correction of Nasolabial
研究概览
简要总结
The study evaluated the safety and efficacy of the Autologous cultured fibroblast for correction of Nasolabial folds and inhibition of skin aging
详细描述
Autologous cultured fibroblast which is obtain from the patient's normal skin is harvested and expanded in an in vitro. Biopsies samples are obtained from the behind of the patient's ear as a source of fibroblasts, then fibroblast cells isolated and expanded through cell culture, and used for the correction of Nasolabial folds, deep wrinkles of the forehead. Prior to final packaging, cell viability is assessed to be at least 85%
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Available and willing to attend all follow-up visits.
- •Age > 18 years.
- •Able and willing to give informed consent
排除标准
- •Known allergy or sensitivity to any cellular products
- •The subject has received a soft tissue augmentation to the area to be treated within the last 6 months.
- •Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study.
- •The subject has received autologous fat transfer in the last 6 months.
- •Subject is suffering from facial Kaposi's sarcoma.
- •The subject has active skin diseases or inflammation on or near the area of injection
- •positive HIV, hepatitis B virus (HBV), hepatitis C virus (HCV)
结局指标
主要结局
Correction of Nasolabial
时间窗: 6 months after transplantation
Evaluate the correction of skin changes after transplantation of autologous fibroblasts by medical examination
次要结局
未报告次要终点