NCT02626780已完成不适用
Adipose-derived Stromal Vascular Fraction (SVF) Injections to Stimulate Hair Regrowth for Androgenetic Alopecia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Incidence of Treatment-emergent Adverse Events (Safety)
研究概览
简要总结
The general objective of this study is to conduct a safety and feasibility study of a single injection of autologous adipose-derived SVF for the treatment of alopecia.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 18 - 60 years of age and older that have been diagnosed with androgenetic alopecia.
- •Subjects will be in good health (ASA Class I-II) with a BMI <
- •Must have at least a 2cm x 2cm spot on the scalp which shows evidence of alopecia without scarring or traumatic injury
- •Able and willing to make the required study visits.
- •Able and willing to give consent and follow study instructions.
- •Must speak, read and understand English
排除标准
- •History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection
- •Allergic to lidocaine, epinephrine, valium or sodium phosphate
- •Individuals with a propensity for keloids
- •Individuals with diminished decision-making capacity will not be included in this research study
- •Current use of anti-inflammatory or anticoagulation medications that affect bleeding or are for bleeding disorders. These include: Plavix, Warfarin (Coumadin, Jantoven, Marfarin). In addition, if any of the following medicines are used two (2) weeks prior to surgery the patient will be ineligible.
- •Use of concomitant treatments, including topical medications, oral medications, meso-therapy, non-ablative fractional laser treatment, low-level laser therapy, interfollicular PRP injection and hair transplantation within the preceding 6 months.
- •All smokers and other tobacco users.
研究组 & 干预措施
SVF Injection
Experimental
Liposuction of a small amount of adipose tissue will be taken from each subject. Stromal Vascular Fraction (SVF) will be disassociated within the GID SVF-2 from the autologous adipose tissue to be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia.
干预措施: GID SVF-2 (Device)
结局指标
主要结局
Incidence of Treatment-emergent Adverse Events (Safety)
时间窗: 6 months
Subjects will be monitored for Adverse events for the duration of the study.
次要结局
- Growth of New Hair(6 months)
研究者
研究点 (4)
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