EUCTR2015-005786-23-ES
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Banc de Sang i Teixits
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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