Phase I, Single Center, Trial to Asses Safety and Tolerability of the Intrathecal Infusion of Ex-vivo Expanded Bone-marrow Derived Mesenchymal Stem Cells for the Treatment of Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
This study is based on preclinical (animal) studies showing that infusing bone marrow-derived mesenchymal stem cells into the spinal fluid may contribute to improving neurologic function in animal models with spinal cord injuries. Bone marrow (BM) contains several types of stem cells that can produce functional cells. This includes cells that could help the healing process of damaged neurologic tissue.
The primary objective of this study is to see if the injection of these cells, obtained from your own bone marrow, is safe. A secondary objective is to evaluate if the treatment can provide functional improvements (neuromuscular control and sensation) in the affected areas.
详细描述
A Phase I, single-center trial to assess the safety and tolerability of an intrathecal infusion (lumbar puncture) of autologous, ex vivo expanded bone marrow-derived mesenchymal stem cells in a well-defined population of spinal cord injury patients.
Safety will be evaluated by neurological and non-neurological tests performed after short-term (1 to 30 days) and long-term (2 to 12 months)follow-up evaluation periods after cell infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Age 18 to 65
- •American Spinal Injury Association Impairment Scale A
- •Clinical evidence of lesions located below c-spine 5 (C-5)
- •Confirmation by MRI of injury level
- •Time between injury and enrollment greater than 2 weeks
- •Ability to provide informed consent
- •Platelet count greater than 100 Thousand/uL at screening
- •INR equal to or less than 1.5
- •Hematocrit less than 30% prior to bone marrow aspiration
- •Spinal cord injury within 60 months of screening
排除标准
- •Anoxic brain injury
- •Inability to provide consent
- •Neurological deficits attributed to lesions above C-5
- •Cerebro-vascular accidents with intracranial hemorrhage, acute brain injuries, meningitis, hydrocephalus or other potential diseases where the pressure in the cerebro spinal fluid is increased
- •Multiple sclerosis
- •Amyotrophic lateral sclerosis
- •Cerebral Palsy
- •Evidence of cancer over the last 3 years prior to enrollment
- •Immunosuppressive diseases
- •Platelet count lower than 100,000
- •White blood count greater than 15,000 unless the patient is on steroids
- •Bleeding disorders
- •Clinical or laboratory evidence of meningitis
- •Skin infection at the infusion site
- •Pregnant or planning to become pregnant
结局指标
主要结局
Safety
时间窗: 12 months
Phase I trial to assess safety of intrathecal infusion of autologous mesenchymal stem cell treatment in spinal cord injury.
次要结局
未报告次要终点