NCT02570932

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Puerta de Hierro University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Mesenchymal Bone Marrow Cell	Suspension in autologous plasma cell of Adult mesenchymal stem cells expanded autologous bone marrow. Route of administration: Intrathecal in subarachnoid space by lumbar puncture.Total dose of 300 x 106 CME, divided in 3 injections of 100 x 106 CME, with intervals of three months between each administration

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-12-04
• Completion: 2017-12-04
• First posted: 2015-10-07
• Last updated: 2018-04-05

Locations

1 site across 1 country: Spain