NCT01669746已完成2 期
A Multi-center, Phase 2 Study of Ji Gami(TM) CN That Evaluates the Efficacy and Safety of ex Vivo-cultured, Expanded, Occipital Autologous Dermal and Epidermal Cells, Injected Into the Hair Loss Area of the Scalp of Male and Female Subjects With Alopecia
Aderans Research Institute8 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2012年6月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 8
- 主要终点
- Change from baseline in hair number
研究概览
简要总结
Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female subjects with hair loss.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers 18-50 years old, inclusive.
- •Women of childbearing potential must use an adequate form of contraception during study participation.
- •Hair loss consistent with Grade III-Vertex, IV, or V based on the based on the Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle, or class 1 or class 2 based on the Ludwig scale.
- •Able to provide informed consent after risks and benefits of the study have been explained.
- •Be willing to undergo all study procedures.
- •Ability to communicate effectively with study personnel.
- •Have no clinically significant disease or abnormal laboratory evaluations taken at the screening visit.
- •Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, minoxidil, finasteride or dutasteride during the course of this study; also agrees to abstain from shaving the head during the course of the study.
排除标准
- •Women who are pregnant or lactating.
- •Known sensitivity to DMEM/F-12 or any component of the study material.
- •Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
- •Subjects who have used minoxidil or any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening.
- •A history of drug or alcohol abuse within 1 year of study enrollment.
- •Participation in any other investigational study within 30 days or six half lives of its biologic activity, whichever is longer, before the scalp excision visit(s), and during the time enrolled in this study.
- •Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
- •Clinically significant symptoms of any acute illness within 30 days prior to excision day.
- •Any condition that compromises the ability to understand or comply with study requirements.
- •Clinically significant abnormal laboratory parameters.
- •A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
- •Clinically significant dermatologic condition in donation or study zones.
- •Prior surgery in the donor or study zones.
- •Insufficient hair or scarring in the donor area that might impact cell growth.
- •Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.
结局指标
主要结局
Change from baseline in hair number
时间窗: 24 weeks post-injection
Change from baseline in hair width
时间窗: 24 weeks post-injection
Time course of any treatment benefit
时间窗: 24 week post-injection
次要结局
未报告次要终点
研究者
研究点 (8)
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