Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease
This trial is active, not recruiting.
|Condition||intervertebral disc disease|
|Treatment||instrumented posterolateral arthrodesis|
|Phase||phase 1/phase 2|
|Sponsor||Red de Terapia Celular|
|Collaborator||Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán|
|Start date||January 2010|
|Trial size||15 participants|
|Trial identifier||NCT01513694, CSM/Fusión/2009|
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).
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Male or female participants from 18 years up to 65 years old.
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.
|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.|
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