NCT05054803

Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Banc de Sang i Teixits · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Spinal Cord Injury Cervical

Interventions

Type	Name	Description
DRUG	WJ-MSC (XCEL-UMC-BETA)	Administration of 2 Intrathecal infusions of WJ-MSC at day 1 and at 3 months
DRUG	Placebo	Administration of 2 Intrathecal infusions of placebo at day 1 and at 3 months

Timeline

• Start date: 2021-10-13
• Primary completion: 2024-01-20
• Completion: 2024-01-20
• First posted: 2021-09-23
• Last updated: 2024-01-24

Locations

2 sites across 1 country: Spain