Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

Phase 1/2 Completed 18 enrolled Blood and Tissue Bank of Catalonia Academic Research Organization (ARO) - VHIR · collab Complexo Hospitalario Universitario de A Coruña · collab Institut Guttmann · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2021-10-13
Primary completion: 2024-01-20
Completion: 2024-01-20

Publications

Background Albu S, Kumru H, Coll R, Vives J, Valles M, Benito-Penalva J, Rodriguez L, Codinach M, Hernandez J, Navarro X, Vidal J. Clinical effects of intrathecal administration of expanded Wharton jelly mesenchymal stromal cells in patients with chronic complete spinal cord injury: a randomized controlled study. Cytotherapy. 2021 Feb;23(2):146-156. doi: 10.1016/j.jcyt.2020.08.008. Epub 2020 Sep 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	WJ-MSC	Cell therapy	1e+06 cells/kg	Intrathecal

Cell Therapy for Chronic Traumatic Cervical Incomplete Spinal Cord Injury

Summary

Timeline

Publications

Drugs

Indications