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)
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|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
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): NCT01700920
|University Hospital of Salamanca|
|Salamanca, Castilla y León, Spain, 37007|