Intrathecal Administration of Expanded Wharton's Jelly Mesenchymal Stem Cells in Chronic Traumatic Spinal Cord Injury

• Status: Completed
• Trial end date: 2020-02-11
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase I/IIa, randomized, double-blind, two-arms, two-dose administration, placebo controlled, two-way crossover clinical trial in which 10 patients from 18 to 65 years of age affected with chronic traumatic spinal cord will enter the study with the objective to assess the safety and to obtain efficacy data in intrathecal administration of expanded Wharton's jelly mesenchymal stem cells.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Banc de Sang i Teixits
• Collaborators: Hospital de Neurorehabilitació Institut Guttmann; Recerca Clínica S.L.; Syntax for Science; Syntax for Science, S.L

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

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 that complicates the MRI interpretation

8. Planned spinal surgery within subsequent 24 month after entering the trial

9. Intrathecal medication or immunosuppressive 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 difficulty for communicating

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 could complicate the participation of the patient 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