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

Phase 1

Completed

• Conditions: Intervertebral Disc Disease
• Interventions: Procedure: Instrumented posterolateral arthrodesis

• Registration Number: NCT01513694
• Lead Sponsor: Red de Terapia Celular

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2012-01-16
• Study First Submitted QC: 2012-01-19
• Study First Posted: 2012-01-20
• Status Verified: 2017-05
• Primary Completion: 2017-05-04
• Study Completion: 2017-05-04
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Clinical

• Box symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.
• Discopathy refractory to conservative treatment (drugs, physical therapy.)
• Evolution greater than or equal to 6 months. Radiological
• Discopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc
• NMR: grades IV and V of Pfirman.

Exclusion Criteria

• Rejection of surgical treatment.
• Systemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.
• Immunosuppressive treatment.
• Congenital or acquired anatomical abnormality that prevents the surgical procedure.
• Neuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.
• High surgical risk (ASA> IV), or contraindication to anesthesia.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MSC seeded onto a phosphate ceramic	Instrumented posterolateral arthrodesis	Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.

Trial Locations

Locations (1)

Trauma Service. Hospital Universitario de Salamanca; 🇪🇸 Salamanca, Castilla-León, Spain