Clinical Trials Logo
  1. Home
  2. Spinal Cord Injury
  3. NCT02570932

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
See also
  Status Clinical Trial Phase
Recruiting NCT02574572 - Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury Phase 1
Recruiting NCT05941819 - ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury N/A
Completed NCT05265377 - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury N/A
Recruiting NCT02331979 - Improving Bladder Function in SCI by Neuromodulation N/A
Completed NCT02777281 - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI N/A
Recruiting NCT02978638 - Electrical Stimulation for Continence After Spinal Cord Injury N/A
Withdrawn NCT02237547 - Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury Phase 1/Phase 2
Completed NCT02161913 - Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers N/A
Completed NCT02262234 - Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study Phase 1/Phase 2
Terminated NCT02080039 - Electrical Stimulation of Denervated Muscles After Spinal Cord Injury N/A
Completed NCT01884662 - Virtual Walking for Neuropathic Pain in Spinal Cord Injury N/A
Completed NCT01642901 - Zoledronic Acid in Acute Spinal Cord Injury Phase 3
Terminated NCT01433159 - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury Phase 2
Completed NCT01471613 - Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury Phase 1/Phase 2
Completed NCT02149511 - Longitudinal Morphometric Changes Following SCI
Completed NCT01467817 - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI) N/A
Completed NCT01025609 - Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
Terminated NCT01005615 - Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury Phase 1/Phase 2
Completed NCT00663663 - Telephone Intervention for Pain Study (TIPS) N/A
Completed NCT01086930 - Early Intensive Hand Rehabilitation After Spinal Cord Injury Phase 3