Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

Banc de Sang i Teixits18 enrolled

Overview

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.

Double-blind, randomized, placebo-controlled, multicenter clinical trial that will include 18 patients affected with chronic traumatic incomplete cervical spinal cord injury who will be randomized 1:1, stratified by center, to one of the 2 treatment arms of the study: WJ-MSC / WJ-MSC (at a dose of 1E6 ± 30% live cells / Kg of weight) or Placebo / placebo. Medication will be administered intrathecally at day 1 and at 3 months. The main objective of the trial is to assess safety at a 12-month follow-up. Secondary objectives include the evaluation of efficacy through clinical response, electrophysiological changes, questionnaires of functionality and quality of life, as well as the presence of anti-HLA antibodies and donor cellularity in the cerebrospinal fluid.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Spinal Cord Injury Cervical

Interventions

WJ-MSC (XCEL-UMC-BETA)DRUG

Administration of 2 Intrathecal infusions of WJ-MSC at day 1 and at 3 months

PlaceboDRUG

Administration of 2 Intrathecal infusions of placebo at day 1 and at 3 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (2)

Hospital de Neurorehabilitació Institut Guttmann

Badalona, Barcelona, Spain

Complexo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Spain

Outcomes

Primary Outcomes

Incidence of adverse events

Adverse events

Time frame: At 12 month follow-up

Secondary Outcomes

American Spinal Injury Association (ASIA) impairment scale

Changes in ASIA score with respect to baseline value as detailed at https://asia-spinalinjury.org/international-standards-neurological-classification-sci-isncsci-worksheet/

Time frame: At 1, 3, 4, 6 and 12 month follow-up

Motor evoked potentials

Changes in motor evoked potentials score with respect to baseline value. Higher scores mean a better outcome