Randomized, Double-blind, Placebo-controlled, Single-centre, Phase I Safety Study of Intradermal Injections of RCS-01 in Male and Female Subjects (50 to 65 Years Old)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 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 profile of RCS-01 injections as compared to placebo injections. This study will also measure the impact these injections will have on skin markers related to aging through evaluation of gene expression profiles.
30 participants will be selected for this study based on their health status, current/past medications, and ability to adhere to protocol-related requirements. At the first visit and after providing informed consent, participants are evaluated against the study inclusion/exclusion criteria and provide blood samples for screening assessments (including virology). If suitable for study participation, participants will provide a biopsy from the scalp from which RCS-01 will be prepared and will have four treatment evaluation sites identified on their buttocks, two on each side.
Study participants will be randomized to one of two treatment subgroups. Participants in the RCS-01 Subgroup (n=24) will receive injections of RCS-01 or placebo or a 'sham' injection (a needle penetration without injection of liquid). Participants in the the Placebo Subgroup (n= 6) will be randomized to receive only injections of placebo or sham injections.
Baseline evaluations of subjects' overall health and skin condition at treatment sites on their buttocks will be performed before receipt of injections at Day 0. In addition to injections delivered at Day 0, the pre-selected treatment evaluation sites will receive intradermal injections of RCS-01 or placebo (cryomedium) or a sham injection four (4) and eight (8) weeks after Day 0 according to a randomization schedule for a total of three (3) injections per treatment site.
All participants will return to the clinic for at least 9 visits during the 52-week follow-up period to monitor long-term safety. At the 12-week time point, 18 randomly-selected participants from the RCS-01 Subgroup will provide biopsies from all injection sites for analysis of skin markers related to aging. At the 26-week time point, the remaining participants will provide biopsies of all injection sites for histopathological analysis.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female Caucasian in good health between the age of 50 and 65 years.
- •Female subjects must be post-menopausal for at least one year or surgically sterile.
- •Signed and dated informed consent and willingness to attend all study visits and complete all procedures required by this protocol.
- •The treatment evaluation sites are of uniform skin color without erythema, dark pigmentation or scars that may confound study results.
排除标准
- •Any transient skin disorder or infections (e.g. pyoderma, tinea corporis, contact or irritative dermatitis, scleroderma etc.) within 20 cm of the treatment evaluation sites or the presence of tattoos near the treatment sites.
- •Subjects diagnosed with psoriasis, lichen planus, vitiligo, systemic scleroderma, or lupus erythematosus.
- •Any condition that, in the investigator's opinion, would impact subject's safety and/or a subject's ability to complete all study related procedures.
- •History of infection with or positive serology results for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis.
- •Presence/history of hypertrophic scars and/or keloids.
- •Subjects diagnosed with cancer with or without chemotherapy treatment within 3 years prior enrollment.
- •Women who are pregnant or nursing.
- •Current use of any medications not permitted in the study
- •Ongoing or recent participation in a cosmetic and/or clinical research study prior to enrolment.
- •Subject not agreeing to avoid UV exposure (sun, solarium) on the nude buttocks during the study period.
- •Known allergy or hypersensitivity to human serum albumin, DMSO, gentamicin, material of bovine origin and/or local anesthetics.
- •Close affiliation with the investigational site (e.g., a close relative of the investigator or a possibly dependent person (e.g., employee or student of the investigational site)).
- •Subjects diagnosed with coagulopathies or significant thrombocytopenia
研究组 & 干预措施
Placebo
cryomedium
干预措施: Sham injection (Device)
RCS-01
Cultured, autologous hair follicle cells suspended in cryomedium
干预措施: RCS-01 (Drug)
RCS-01
Cultured, autologous hair follicle cells suspended in cryomedium
干预措施: Placebo (Drug)
RCS-01
Cultured, autologous hair follicle cells suspended in cryomedium
干预措施: Sham injection (Device)
Placebo
cryomedium
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of local adverse events
时间窗: 52 weeks after first injection
Within-patient comparison of the local (reported at treatment evaluation sites) adverse event profile between treatment evaluation sites treated with RCS-01 or placebo. The local adverse event profile is defined by the incidence, relationship to treatment, severity and seriousness of adverse events reported at the treatment evaluation sites.
次要结局
- Incidence of adverse events(52 weeks after first injection)
- Incidence of abnormalities in skin structure(52 weeks after first injection)
- Incidence of changes in markers related to skin aging(12 weeks after first injection)