NCT04465929No Longer Available不适用
Expanded Access - The Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury (PNI)
W. Dalton Dietrich1 个研究点 分布在 1 个国家开始时间: 2020年7月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 发起方
- 试验地点
- 1
研究概览
简要总结
Emergency expanded access for a single patient was granted to receive autologous human Schwann cell (ahSC) augmentation of nerve autograft repair after severe peripheral nerve injury (PNI).
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 16 Years 至 16 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Persons with severe sciatic nerve injury, brachial plexus injury, and/or major injury at the upper or lower extremity with nerve loss within previous year;
- •Peripheral nerve injury with large gap (5 - 10 cm) between healthy nerve endings;
排除标准
- •Persons unable to safely undergo an MRI (may include persons with an implanted device or metallic fragments which may interfere with MRI safety);
- •Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest (may include amputation or major injury to lower limb, or disease affecting the sural nerve);
- •Persons with severe peripheral nerve injury gap length > 10 cm in length;
- •Persons with history of radiation or local cancer in area of nerve injury, including primary tumors of the nerve;
- •Pregnant women or a positive pregnancy test in those women with reproductive potential prior to transplantation;
- •Presence of disease that might interfere with participant
研究者
W. Dalton Dietrich
Professor
University of Miami
研究点 (1)
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