Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events
研究概览
简要总结
Human Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSC) and Bone Marrow Mononuclear Cells (BMMC) from the patient injected into the spinal fluid intrathecally and injected intravenously (IV) is a safe and therapeutic procedure for spinal cord injury (SCI) patients.
详细描述
The proposed study will assess primary safety and secondary efficacy endpoints of autologous bone marrow mononuclear cells and allogeneic human umbilical cord-derived mesenchymal stem cells administered to 20 male and female subjects between ages of 18-50 with spinal cord injury. These cells will be administered intrathecally and intravenously multiple times over the course of one month.
The primary objective is freedom from treatment-associated adverse events at 3 and 12 months post-treatment. Secondary objective will be efficacy at baseline, 3 months and 12 months and will be quantified based on the following: American Spinal Cord Injury Association (ASIA) classification and the Frankel Scale.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women between age 18 and 50
- •Paraplegics and quadriplegics with complete or incomplete spinal cord injuries.
- •Willingness to undergo bone marrow derived autologous cell therapy.
- •Ability and willingness to make regular visits to hospital and follow ups during the protocol procedure and comply with all medical instructions
- •Traumatic Injury of spinal cord with complete or partial damage by Magnetic Resonance Imaging (MRI) and injury level below C4
- •ASIA impairment scale from A - C
- •Must have proof of health insurance in country of residence.
- •Signed informed consent
排除标准
- •Pre- existing or current systemic disease such as lung, liver (exception: history of uncomplicated hepatitis A), gastrointestinal, cardiac, Human Immunodeficiency Virus (HIV)
- •History of life threatening allergic- or immune-mediated reaction
- •Hemodynamic instability
- •Peripheral muscular dystrophy
- •Lactating or pregnant woman
- •Women capable of childbearing unwilling to use multiple forms of contraception
- •Alcohol drug abuse /dependence
- •Positive test result for hepatitis A and Hepatitis B OR C
- •Major-traumatic brain injury and psychiatric illness
- •Open injuries
- •Active infectious diseases
- •Life expectancy of less than one year due to terminal condition
- •Neurodegenerative diseases
- •Primary hematologic diseases
- •Any of the following medications that cannot be discontinued one week prior to the first stem cell administration and throughout the course of treatment. (1 week before visit 2 through one week after visit 12)
- •Antibiotics
- •Antifungals
- •Antivirals
- •Blood thinners (to avoid bleeding risk during bone marrow aspiration and IT procedures)
- •High doses of Vitamin D or fish oils (since these might prolong bleeding times)
- •Bone reflecting increased risk for spinal puncture
- •Hepatic dysfunction
- •Other medical complications that contraindicate surgery, including major respiratory complications
- •Participation in another clinical trial
- •Coagulopathies
- •Uncorrected coagulopathy during the baseline period defined as: International Normalized Ratio (INR) > 1.4; Partial Thromboplastin Time (PTT) > 35 sec; Platelet Count (PLT) < 100,
- •Pre-injury history of seizure disorder and/or neurological impairment where participation in age-appropriate pain rating scales would not be practical or possible
- •Subject does not sign informed consent form
结局指标
主要结局
Number of patients with adverse events
时间窗: 12 weeks, 52 weeks
12 and 52 weeks after final treatment
次要结局
- Number of subjects with a change in American Spinal Injury Association (ASIA) score from baseline(12 weeks, 52 weeks)
- Number of subjects with a change in Frankel Scale score from baseline(12 weeks, 52 weeks)