Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Spinal Cord Injury . It is Self Funded (Patients' Own Funding) Clinical Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Improvement in overall sensory for motor control using Frankel score.
研究概览
简要总结
This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.
详细描述
A spinal cord injury (SCI) refers to any injury to the spinal cord that is caused by trauma instead of disease.[1] Depending on where the spinal cord and nerve roots are damaged, the symptoms can vary widely, from pain to paralysis to incontinence.[2][3] Spinal cord injuries are described at various levels of "incomplete", which can vary from having no effect on the patient to a "complete" injury which means a total loss of function.Injuries at any level can cause:Increased muscle tone (spasticity),Loss of normal bowel and bladder control (may include constipation, incontinence, bladder spasms),Numbness,Sensory changes Pain,Weakness, paralysis. This Study is a single arm,Phase I/II , single centre trial to check active comparing the safety and efficacy of Bone marrow derived autologous cell(100 million per dose) trial to be conducted for 36 months.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient should suffer from Spinal cord injury.
- •willingness to undergo bone marrow derived autologous cell therapy.
- •patient those provide fully Informed consent form for the study.
- •Ability and willingness to regular visit to hospital and follow up during the protocol Procedures.
- •traumatic Injury of spinal cord with complete or partial damage by MRI and Spinal cord injury level should be below C4
排除标准
- •Patient with pre- existing or current systemic disease such as Lung, liver,(exception:history of uncomplicated hepatitis A)gastrointestinal,cardiac , immunodeficiency(HIV)
- •History of life threatening allergic or immune - mediated reaction.
- •haemodynamically unstable patients.
- •patient suffer from peripheral muscular dystrophy.
- •lactating and pregnant woman
- •alcohol drug abuse /dependence
- •positive test result for hepatitis A and Hepatitis B OR C
- •Major-traumatic brain injury and patient with psychiatric illness .
结局指标
主要结局
Improvement in overall sensory for motor control using Frankel score.
时间窗: 6 month
次要结局
- Improvement in pain sensation and Significant changes in Muscle Tones from base line(6 month)
- -Improvement in sensory and motor dysfunction using ASIA( American spinal cord injury association ) Scale(6 month)
- Significant changes in Muscle Tones and Improvement in pain sensation from base line(6 month)
研究者
Dr. Sachin Jamadar
C0- Investigator
Chaitanya Hospital, Pune