Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

Spinal Cord Injury Cervical Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury Cervical
• Wounds and Injuries

• NCT number: NCT05054803
• Study type: Interventional
• Source: Banc de Sang i Teixits
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 13, 2021
• Completion date: January 20, 2024