NCT01190865已完成1 期
A Phase I Study Investigating the Survival of HP802-247 Allogeneic Cells in Excisional Acute Cutaneous Wounds
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Healthpoint
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy.
研究概览
简要总结
The goal for this study is to examine the persistence of growth arrested,allogeneic,male-donor keratinocytes and fibroblasts when applied as product HP802-247 to the surface of acute excisional wounds in health female volunteers, as measured using Y-STR for detection of Y-chromosome.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent.
- •Female, 18 years of age or older.
- •Any race or skin type, provided that there are no tattoos within 5 cm of the wound target, and the gentian violet surgical marker produces a clearly visible mark on the skin.
- •Willing to make all required study visits and, in the opinion of the Investigator, able to follow instructions.
- •Willing to undergo the repeated biopsy procedures.
- •Willing to undergo verification of sex chromosome status.
排除标准
- •Males, or phenotypic females bearing Y-chromosome genetic material [e.g., 46,X,(r)Y; 46,X,der(X)t(X;Y); sex reassignment surgery].
- •Contraindications or hypersensitivity to the use of the study medications or their components (e.g., history of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin B).
- •History of keloid formation or hypertrophic scarring.
- •Participation in any interventional clinical trial within 30 days prior to screening.
- •History of prolonged bleeding, bleeding into joints, easy bruising following minor trauma, clotting factor deficiency, or current use of anticoagulants or platelet inhibitors.
- •Any medical condition which, in the opinion of the Co-Investigator, may interfere with normal wound repair.
- •Current therapy with drugs or biologics intended to function as immuno-suppressants, chronic (> 10 days) oral corticosteroids, or any concomitant medication which, in the opinion of the Co-Investigator, may interfere with normal wound repair.
结局指标
主要结局
Identification of the Full Set of Y-chromosome Short Tandem Repeats in Each Bioopsy.
时间窗: Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks
The primary efficacy variable was detection of the full set of 17 Y STR loci. If all loci amplified such that a clear identification of a donor was possible, the test result was categorized as positive. If fewer loci amplified such that identification of the donor was not possible in a forensic setting, the result was categorized as negative. Descriptive statistics are presented for this variable.
次要结局
- Time in Days to 50% Correct Identification (ID50) of the Implanted Male DNA 17 Loci in Female Volunteers, With Regard to Three DNA Profile Types, Including Partial DNA Profile, > 50% DNA Profile, and Full (or Complete) DNA Profile.(Cohorts of 3 subjects were biopsied at weekly intervals for 8 weeks)
研究者
研究点 (1)
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