NCT05541250招募中1 期
Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve Injury (PNI)
W. Dalton Dietrich2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年5月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-related Adverse Events (AEs)
研究概览
简要总结
The primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with severe sciatic nerve injury, brachial plexus injury, and/or major nerve injury at the upper or lower extremity within previous year;
- •Between the ages of 18 and 65 at last birthday
排除标准
- •Persons unable to safely undergo an MRI;
- •Persons with pre-existing conditions that would preclude satisfactory sural nerve harvest;
- •Persons with severe peripheral nerve injury gap length > 10 cm;
- •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 enrollment;
- •Presence of disease that might interfere with participant safety, compliance, or evaluation of the condition under study;
- •History of active substance abuse;
- •Persons allergic to gentamicin;
- •Persons who test positive for HIV or Hepatitis B or C virus.
- •Persons unable to provide consent independently due to cognitive impairment
研究组 & 干预措施
Autologous Human Schwann Cell (ahSC) Group
Experimental
Participants in this group will undergo a sural nerve biopsy followed by ahSC transplant
干预措施: Autologous Human Schwann Cell (Biological)
结局指标
主要结局
Incidence of Treatment-related Adverse Events (AEs)
时间窗: Up to 2 years
Safety will be reported as the incidence of treatment-related AEs as assessed by treating physician
次要结局
- Motor Recovery as assessed using the MRC Grading Scale(Up to 2 years)
- Sensory recovery as assessed by Pin-Prick Evaluation(Up to 2 years)
- Sensory recovery as assessed by the 2-Point Discrimination Evaluation(Up to 2 years)
研究者
W. Dalton Dietrich
Professor
University of Miami
研究点 (2)
Loading locations...
相似试验
No Longer Available
不适用
Emergent Expanded Access for ahSC Augmentation of Nerve Autografts After Severe Peripheral Nerve Injury.Sciatic Nerve InjuryNCT02510079W. Dalton Dietrich
已完成
1 期
Autologous Human Schwann Cells in Peripheral Nerve RepairPeripheral Nerve InjuriesNCT03999424W. Dalton Dietrich5
已完成
1 期
Safety of Autologous Human Schwann Cells (ahSC) in Subjects With Subacute SCIParaplegiaSpinal Cord InjuryNCT01739023W. Dalton Dietrich9
已完成
1 期
The Safety of ahSC in Chronic SCI With RehabilitationParaplegiaQuadriplegiaTetraplegiaSpinal Cord InjuryNCT02354625W. Dalton Dietrich8
No Longer Available
不适用
Expanded Access for Single Patient Treatment of Autologous Human Schwann Cells (ahSC) for Peripheral Nerve RepairSciatic Nerve InjuryNCT02480777W. Dalton Dietrich