Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease
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|ClinicalTrials.gov Identifier: NCT01513694|
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : June 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intervertebral Disc Disease||Procedure: Instrumented posterolateral arthrodesis||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||May 4, 2017|
|Actual Study Completion Date :||May 4, 2017|
Experimental: MSC seeded onto a phosphate ceramic
Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513694
|Trauma Service. Hospital Universitario de Salamanca|
|Salamanca, Castilla-León, Spain, 37007|