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Administration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries

Spinal Cord Injury Clinical Trial

Official title:
Intrathecal Administration (Pattern 100/3) of Expanded Autologous Adult Bone Marrow Mesenchymal Stem Cells in Established Chronic Spinal Cord Injuries

Clinical Trial Summary

The purpose of this study is to analyze the potential clinical efficacy of intrathecal administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow mesenchymal stem cells in the treatment of patients with established chronic spinal cord injury (LEM).

Clinical Trial Description

This is a clinical trial phase II, single-center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury.

Patients are treated with repeated administrations of in vitro expanded autologous adult bone marrow mesenchymal stem cells.

The expanded cells are administered in the subarachnoid space by lumbar puncture. The minimum duration of the follow-up period for each patient is 10 months after the first administration.

The study duration is 24 months, that include recruiting, treatment and follow period for all patients. For each patient at the first day will be administered the first cellular doses, then 3 doses will be administrated every 3 months. At the end of the clinical trial, a completed check of all obtained parameters will be performed.

It is considered Day 1 for each patient the first day of the first cell administration. The remaining 2 doses will be administered at intervals of 3 months from the first administration (of the treatment period after, months 4 and 7). At the end of the study will be performed a full assessment of the variables collected along the study trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02570932
Study type Interventional
Source Puerta de Hierro University Hospital
Contact
Status Completed
Phase Phase 2
Start date July 2015
Completion date December 4, 2017
View Details
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