Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients

Cairo University1 个研究点分布在 1 个国家目标入组 80 人开始时间: 2005年5月最近更新: 2009年1月5日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方: Cairo University
入组人数: 80
试验地点: 1
主要终点: Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.

研究设计

研究类型: Interventional
干预模型: Parallel
主要目的: Treatment
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 10 Years 至 36 Years（Child, Adult）
性别: All
接受健康志愿者: 否

入选标准

•Traumatic spinal cord injury
•No concomitant systemic disease
•No progress on physiotherapy for at least 6 months
•Duration of injury from 10 months to 3 years

排除标准

•Non-traumatic spinal cord injury whether transverse myelitis or demyelination
•Concomitant systemic disease
•Progress can be observed on physiotherapy
•Acute injury or duration of injury less than 10 months

结局指标

主要结局

Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI.

时间窗: 18 months

次要结局

Efficacy of BM cell transplant in improving neurological functions in patients with chronic SCI. Improvement in motor, sensory and sphincteric functions, and quality of life using ASIA scores and MRI.(18 months)

研究者

发起方

Cairo University

申办方类型

Other

研究点 (1)

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