A phase I/II, randomized, double-blind, placebo-controlled, parallel, 2-arms clinical trial to assess the safety and efficacy of intrathecal administration of WJ-MSC in chronic traumatic cervical incomplete spinal cord injury

Banc de Sang i Teixits0 个研究点目标入组 18 人开始时间: 2022年7月11日最近更新: 2022年8月8日

试验速览

暂无简介。

•1.Single spinal cord injury lesion caused by trauma
•2.Affected cord segments between C1 and T1, confirmed by magnetic resonance
•3.Incomplete lesion (ASIA B, C or D)
•4.Chronic disease state (between 1 and 5 years after the injury)
•5.Patients from 18 to 70 years of age, both sexes
•6.Life expectancy > 2 years
•7.Residence near the center during study participation and 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 16
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2

•1.Mechanic ventilation
•2.Penetrating trauma affecting the spinal cord
•3.Pregnant woman or without proper anticonceptive measures according to the investigator, or breath feeding
•4.Planned spinal surgery within subsequent 12 month after entering the trial
•5.Neurodegenerative diseases
•6.Significant abnormal laboratory tests that contraindicates patient's participation in the study
•7.Neoplasia within the previous 5 years, or without complete remission
•8.Patient with communication difficulties
•9.Simultaneous participation in another clinical trial or treated with an investigational medicinal product the previous 30 days, that could interfere in the results of the study
•10.Previous treatment with and advanced Therapy Medicinal Product (cell therapy)
•11.Contraindication for lumbar punction
•12.Contraindication or inability to follow a rehabilitation program
•13. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
•14.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.

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