NCT06588426招募中不适用
Clinical Readiness Skin Punch Biopsy Sample Collection
HeartWorks, Inc.1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Successful manufacture of induced pluripotent stem cells
研究概览
简要总结
This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.
详细描述
This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 and older
- •Congenital heart disease
- •Likely to qualify for an active clinical trial under IND 28611 in the future
排除标准
- •Previous cardiac transplantation
- •Unable or unwilling to consent
- •HIV diagnosis
- •Hepatitis diagnosis
结局指标
主要结局
Successful manufacture of induced pluripotent stem cells
时间窗: 12 months
Outcome measured will be the manufacture of iPSC that meets pre-determined acceptance criteria.
次要结局
未报告次要终点
研究者
研究点 (1)
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