NCT01513694

Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease

Clinical Trial Phase I / II Prospective, Open, Non-randomized for Treatment of Lumbar Intervertebral Degenerative Disc Disease With Posterolateral Instrumented and Autologous Mesenchymal Stem Cells.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Red de Terapia Celular · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM).

Conditions

• Intervertebral Disc Disease

Interventions

Type	Name	Description
PROCEDURE	Instrumented posterolateral arthrodesis	Cell suspension of mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products. They used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight. Dosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery.

Timeline

• Start date: 2010-01-01
• Primary completion: 2017-05-04
• Completion: 2017-05-04
• First posted: 2012-01-20
• Last updated: 2017-06-02

Locations

1 site across 1 country: Spain