Overview

Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

Status:
Not yet recruiting

Trial end date:
2025-10-01

Target enrollment:
0

Participant gender:
All

Summary

This is a double-blind, randomized, placebo-controlled, multicenter clinical trial in which 18 patients affected with chronic traumatic incomplete cervical spinal cord injury will be randomized to either the active treatment (2 doses of intrathecal WJ-MSC 3 months apart) or to placebo (2 intrathecal infusions, 3 months apart). Thereafter, patients will be followed-up for 12 months for safety and efficacy assessment.

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Banc de Sang i Teixits

Collaborators:

Academic Research Organization (ARO) - VHIR
Institut Guttmann

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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