PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells (CSM/ON/2011)
|ClinicalTrials.gov Identifier: NCT01700920|
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : March 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteonecrosis of the Femoral Head||Procedure: bone marrow aspirate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Mesenchymal Stem Cell
Cell suspension 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 employ a minimum dose of 0.5 x 106 MSC / kg and a maximum of 1, 0x106 CSM / kg of patient weight.
Pharmaceutical form: Suspension cell Route of administration: local implant intraosseous injection with trocar in the femoral head.
|Procedure: bone marrow aspirate|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01700920
|University Hospital of Salamanca|
|Salamanca, Castilla y León, Spain, 37007|