Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01513694
|Trauma Service. Hospital Universitario de Salamanca|
|Salamanca, Castilla-León, Spain, 37007|