NCT07099066尚未招募不适用
Generation of Skin Fibroblast Banks, Urine-derived Cells and Biomarker Isolation From Patients With Amyotrophic Lateral Sclerosis (Als)
Human Cell Design0 个研究点目标入组 50 人开始时间: 2025年9月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 主要终点
- Cell banking
研究概览
简要总结
The aim of this research is to establish different cell banks from patients with amyotrophic lateral sclerosis (ALS).
详细描述
The objective of this research is to:
- Create banks of skin fibroblasts from skin biopsy samples
- Create banks of urine-derived cells (UDCs) from urine samples
- Build a collection of blood samples to enable isolation of biomarkers.
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
- •Subjects over 18 years old;
- •Subjects who have given their consent and signed an informed, free and express consent form;
- •Subjects with diagnosed ALS;
- •Subjects affiliated to or benefiting from a social security scheme.
排除标准
- •Subjects with contraindications to the collection of biological samples (blood, skin, urine).
- •Subjects undergoing treatment likely to affect hemostasis (anticoagulants, platelet anti-aggregants, etc.) in the month prior to inclusion and during the study;
- •Subjects with hereditary or acquired haemostasis disorders;
- •Subjects who have undergone physical treatment (radiotherapy, etc.) on the area to be biopsied in the last 6 months;
- •Lidocaine-intolerant subjects;
- •Subjects who have reached the age of majority and are subject to a protective measure or are unable to express their consent.
结局指标
主要结局
Cell banking
时间窗: 8 months
Number of cell batches cryopreserved that meet predefined quality criteria (cell viability ≥ 80%, absence of mycoplasma). Data will be summarized as percentage of compliant batches over total batches produced.
次要结局
未报告次要终点
研究者
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