CTRI/2009/091/000613已完成2 期
Prospective, randomized, open-labeled, parallel group clinical study to evaluate safety and efficacy of R-HSC-001 in patients with Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Patients of ages more than 18 and less than 70 years (18 and 70 years inclusive)
- •2. Patients with acute thoracic (T2 to T12) or cervical spinal cord injury (C1-T1) and Frankel score of at least B. Patients with complete or partial transaction/damage as shown by MRI.
排除标准
- •1. Significant head trauma or any other injury which in the opinion of the investigator, is sufficient to interfere with the assessment of spinal cord function or otherwise compromise the validity of the patient?s data
- •2.Hemodynamically unstable patients
- •3.History of or concurrent autoimmune disease or an acute episode of Guillain-Barre syndrome
- •4.AST/ALT of 2.5 X upper limit of normal and Serum Creatinine 2 X upper limit of normal
- •5.Severe skin infection and osteomyelitis /or at the site of bone marrow aspiration potentially limiting the procedure
- •6.Presence of a primary hematological disease or any coagulation abnormalities or concomitant treatment with coumarin anti-coagulant
- •7.Women of child-bearing potential unwilling to use effective barrier method of contraception for the duration of the study
- •16.Alcohol and/or drug abuse/dependency
- •17.Pregnant or nursing women
- •18.Any condition that in the judgment of the investigator would place the patient at undue risk
- •19.History of receiving an investigational product within 30 days prior to enrollment in this study
研究者
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