NCT01909154

Safety Study of Local Administration of Autologous Bone Marrow Stromal Cells in Chronic Paraplegia

Phase I Pilot Study to Evaluate the Security of Local Administration of Autologous Stem Cells Obtained From the Bone Marrow Stroma, in Traumatic Injuries of the Spinal Cord

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Puerta de Hierro University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm the security, and detect the effect of the local administration in damaged nervous tissue, of autologous bone marrow stromal cells.

Detailed description

It is a clinical trial phase I, single center, non-randomized, uncontrolled, open prospective follow-up of a cohort of patients with chronic spinal cord injury (SCI) who were treated with autologous stromal cells of the bone marrow administrated locally (subarachnoid and intramedullar) by intrathecal microinjection and three months later, by lumbar subarachnoid administration. The minimum follow-up duration for each patient is 12 months after the first administration, or until death, if it occurs it before.

Conditions

• Spinal Cord Injury

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal stromal cell therapy	Stem cells administration locally

Timeline

• Start date: 2013-03-01
• Primary completion: 2014-04-01
• Completion: 2015-03-01
• First posted: 2013-07-26
• Last updated: 2019-03-29
• Results posted: 2019-03-29

Locations

1 site across 1 country: Spain