CTRI/2013/10/004109进行中（未招募）2/3 期
A clinical trial to study the safety and efficacy of Bone marrow derived Autologous cells for the treatment of Chronic Paraplegia
Arvind Bagul1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年1月3日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement in overall sensory for motor control using Frankel score. - Improvement in sensory and motor dysfunction using ASIA scale (American spinal cord injury association)
研究概览
简要总结
This study is a single arm, single center trial to check active comparing the safety and efficacy of Bone marrow derived autologous cells (100 million per dose). Trial to be conducted for 36 months in 100 patients with Chronic Paraplegia in India. Primary outcome measures are Improvement in overall sensory for motor control using Frankel score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 3.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Should suffer from Chronic Paraplegia due to pyramidal or extra-pyramidal cause.
- •Willingness to undergo Bone marrow derived Autologous cell therapy.
- •Ability to comprehend the explained protocol and thereafter give an informed consent as well as sign the required Informed Consent Form (ICF) for the study.
- •Ability and willingness to regularly visit the hospital / clinic for follow up during the follow up period / on prior agreed time points as per the protocol.
排除标准
- •Patients with pre-existing or current systemic disease such as lung , liver (exception: history of uncomplicated hepatitis A) gastrointestinal , cardiac, immunodeficiency (including HIV) or any other condition determined by history or laboratory investigation that could cause a neurological defect (including syphilis, clinically relevant polyneuropathy) etc.
- •History of life threatening allergic or immune-mediated reaction.
- •Haemodynamically unstable subjects.
- •Subjects suffering from peripheral muscular dystrophy.
- •Severe skin infection and osteomyelitis/ or at the site of bone marrow aspiration potentially limiting the procedure.
- •Positive test results for Hepatitis A and Hepatitis B or C.
- •Alcohol and / or drug abuse/ dependence.
- •Subjects with primary or secondary diabetes, insulin dependence or with serum creatinine > 1.5 mg/dL.
结局指标
主要结局
Improvement in overall sensory for motor control using Frankel score. - Improvement in sensory and motor dysfunction using ASIA scale (American spinal cord injury association)
时间窗: 6 weeks,3,6,9 months
次要结局
- Improvement in bowel and bladder control(3,6,9 months)
研究者
研究点 (1)
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