Randomized, Single-centre, Double-blind, Placebo-controlled, Phase I / IIa Study to Evaluate the Safety and Efficacy of Human Autologous Hair Follicle Dermal Sheath Cup Cells (DSCC) in Women and Men With Androgenetic Alopecia.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Incidence of local adverse events
研究概览
简要总结
The primary purpose of this study is to assess the safety of performing injections of human autologous hair follicle cells. The study will also measure the impact these injections will have on hair growth.
20 patients will be selected for participation in this study (10 males and 10 females) based on their health status, current/past medications, and ability to adhere to protocol-related requirements. All patients will have evidence of mild to moderate androgenetic alopecia (AGA) involving the vertex area of the scalp as defined by the Ludwig (female) or Norwood (male) scales.
At the first visit and after completing informed consent, patients provide a blood sample that will be tested for human immunodeficiency virus (HIV), hepatitis, and syphilis one week before having a biopsy from the back of their scalp. The provided scalp biopsy is then processed to isolate hair follicle cells which are then replicated. Patients return to the clinic for injections of their own replicated cells (autologous cells) in medium (verum) and medium alone (control) into two pre-selected treatment areas in their scalp. Assessments of the safety/tolerability of these injections will take place over the next 60 months both at in-clinic visits and telephone follow-up visits. At these visits patients will have their overall health assessed as subjective and objective assessments of the areas that were injected either with verum or control. During the first 24 months of follow-up, digital images will be taken of the scalp and of the two treatment areas injected with either verum or control. Furthermore at 6, 12, and 24 months post-injection, four patients (2 male and 2 female) at each time point will provide biopsies of the injection sites for histopathological analysis. At the 60 month time point, any patients not previously providing biopsies for histopathological analysis will provide biopsies. Total duration of patient participation is approximately 63 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the age of 18 and 55 years and in good health having evidence of mild to moderate androgenetic alopecia (AGA) involving the vertex area of the scalp. Female patients with androgenetic alopecia (AGA) characterized as vertex pattern type II or type III of the Ludwig Scale qualify for inclusion in this study. Males with androgenetic alopecia (AGA) involving the vertex area of the scalp, characterized as type III vertex- type VI on the Norwood Scale qualify for inclusion in the study.
- •Willingness to provide written informed consent for participation in the study, attend all study visits and complete all procedures required by this protocol.
- •The test areas (areas to be injected) are of uniform skin color without erythema, dark pigmentation or scars that may confound study results.
- •Willingness to forego the use cosmetic or medical products for hair loss throughout the course of the study.
- •Females must be post-menopausal for at least one year, surgically sterile, or, if of childbearing potential, using highly-effective methods of birth control. This method of contraception must be used at least 4 weeks prior to and during the entire duration of the clinical trial.
排除标准
- •Use of any product (medication or otherwise) which interferes with the hair growth cycle.
- •Any systemic medical treatment for hair loss (for example, Finasteride, Minoxidil, Dutasteride, or antiandrogens) within the last 12 months.
- •Start of contraception treatments containing chlormadinone or cyproterone acetate within the last 12 months.
- •Women who are pregnant or nursing.
- •Presence of any medical condition that influences the hair growth cycle (for example, alopecia areata, lichen planopilaris, lupus erythematosus, severe seborrheic eczema, psoriasis capitis or tinea capitis, untreated thyroid gland disease/goiter development, auto-immune diseases, etc.).
- •Any condition that, in the investigator's opinion would impact patient safety and/or a patient's ability to complete all study related procedures (for example, psychiatric illness, drug addiction, alcoholism, etc.).
- •Infection with human immunodeficiency virus (HIV), hepatitis, or syphilis.
- •Subjects diagnosed with cancer with or without chemotherapy treatment.
- •Sudden hair loss within the last 4 months unrelated to normal seasonal hair shedding or androgenetic alopecia (AGA).
- •Subjects in the process of or having completed surgical correction of hair loss in the past 24 months.
- •Participation in a cosmetic and/or pharmaceutical research study.
结局指标
主要结局
Incidence of local adverse events
时间窗: six months post-injection
Assessment of the local (at pre-selected treatment sites) safety profile of autologous hair follicle cells at six months compared to control as defined by adverse events (AEs) with respect to their causality, incidence, severity and seriousness
次要结局
- Incidence of local adverse events(12, 24 and 60 months post-injection)
- Systemic adverse events(during 60-month observation period)
- Histopathological analysis(6, 12. 24 and 60 months post-injection)
- Hair Growth(6 months post-injection and over 24-month observation period)
- Complete safety profile(during 60-month observation period)