Autologous Transplantation of Cultured Fibroblast for Facial Contour Deformities
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2-point shift in at least one treated area using a standardized 7-point photoguide
研究概览
简要总结
Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good and radiant skin. However despite all the care taken passage of time will bring about conditions that will automatically lead to skin aging, which may require certain therapeutic, care. Fibroblasts are cells that synthesize the extracellular matrix and collagen and play a critical role in wound healing and maintenance of healthy skin. Loosing of fibroblast cell is the main problem in aging and wrinkles and non-healed skin wounds. Therefore proliferation of skin fibroblast along with differentiation of stem cells in the skin tissue is the best method for healing.
详细描述
Autologous cultured fibroblast is derived from in vitro expansion of fibroblasts harvested from the patient's normal skin. Biopsies from behind a patient's ear are the source of fibroblasts, which are isolated, expanded through cell culture, and used for the correction of facial contour deformities such as nasolabial folds, glabellar crease, deep wrinkles of the forehead, and acne scars. Prior to final packaging, cell viability is assessed to be at least 85%.
Each single use container of autologous cultured fibroblasts has approximately 20 million cells aseptically processed and suspended in 1 mL of sterile, buffered Dulbecco's Modified Eagles Medium (DMEM). Both the biopsy transport media and the cell culture media contain gentamicin. Residual quantities of gentamicin up to 5 µg/mL may be present in the Cell product
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 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 collagen fillers
- •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, HBV, HCV
研究组 & 干预措施
Fibroblast
Injection of autologous cultured fibroblast
干预措施: Fibroblast (Biological)
Fibroblast
Injection of autologous cultured fibroblast
干预措施: fibroblast and gel (Biological)
结局指标
主要结局
2-point shift in at least one treated area using a standardized 7-point photoguide
时间窗: 6 months
次要结局
未报告次要终点