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

Study Overview
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Brief Summary
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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).

Official Title
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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.

Conditions
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Intervertebral Disc Disease

Intervention / Treatment
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* Procedure: Instrumented posterolateral arthrodesis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MSC seeded onto a phosphate ceramic<br>Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic. | Procedure: Instrumented posterolateral arthrodesis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesenchymal Stem Cells, Stem Cells, Intervertebral disc disease