EUCTR2015-005786-23-ES进行中（未招募）1 期
A phase I/IIa, randomized, double-blind, single-dose, placebo controlled, two-way crossover clinical trial to assess the safety and to obtain efficacy data in intrathecal administration of expanded Wharton?s jelly mesenchymal stem cells in chronic traumatic spinal cord injury - Wharton?s jelly mesenchymal stem cells for chronic traumatic spinal cord injury
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Single spinal cord injury lesion caused by trauma
- •2. Affected cord segments between T2 and T11, confirmed by magnetic resonance
- •3. Complete paraplegia (ASIA A)
- •4. Chronic disease state (between 12 months and 5 years after the injury)
- •5. Patients from 18 to 65 years of age, both sexes
- •6. Life expectancy > 2 years
- •7. Confidence that the patient will attend the follow-up visits.
- •8. Given informed consent in writing
- •9. Patient is able to understand the study and its procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Mechanic ventilation
- •2. Lesion affecting multiple levels
- •3. Lesion length superior to 3 spinal cord segments, assessed by magnetic resonance
- •4. Penetrating trauma affecting the spinal cord
- •5. Positive serology to HIV, HBV, HCV and or syphilis
- •6. Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
- •7. Use of metal implants difficulting the MRI
- •8. Planned spinal surgery within subsequent 24 month after entering the trial
- •9. Intrathecal medication or immunossupresive drugs the previous 60 days.
- •10. Neurodegenerative diseases
- •11. Significant abnormal laboratory tests that contraindicates patient's participation in the study.
- •12. Neoplasia within the previous 5 years, or without complete remission
- •13. Patient with communication difficulties
- •14. Participation in another clinical trial or treated with an investigational medicinal product the previous 60 days
- •15. Contraindication for lumbar punction
- •16. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
- •17. The patient does not accept to be followed-up for a period that could exceed the clinical trial length
- •(*) Allowed anticonceptive methods are: hormones, intrauterine dispositive, barrier methods, voluntarily sterilization or menopause >1year duration.
研究者
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