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

Intervertebral Disc Disease Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01513694
• Other study ID #: CSM/Fusión/2009
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 16, 2012
• Last updated: June 1, 2017
• Start date: January 2010
• Est. completion date: May 4, 2017

Study information

• Verified date: May 2017
• Source: Red de Terapia Celular
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 4, 2017
• Est. primary completion date: May 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Intervertebral Disc Disease
• Intervertebral Disc Displacement
• Spinal Diseases

Intervention

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.

Locations

Country	Name	City	State
Spain	Trauma Service. Hospital Universitario de Salamanca	Salamanca	Castilla-León

Sponsors (3)

Lead Sponsor	Collaborator
Red de Terapia Celular	Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán, Spanish National Health System

Country where clinical trial is conducted

Spain, 

External Links

•   Salamanca University Foundation
•   Spanish cell therapy network (TerCel)
•   Spanish Health Institute Carlos III