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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01700920
First Posted: October 4, 2012
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Spanish National Health System
Information provided by (Responsible Party):
Red de Terapia Celular
October 2, 2012
October 4, 2012
March 30, 2017
July 2012
December 2015   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01700920 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
The purpose of this study is to analyze the safety and feasibility of direct administration intrafemoral mesenchymal stem cells (MSCs) in vitro expanded autologous treatment of patients with femoral osteonecrosis.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Osteonecrosis of the Femoral Head
Procedure: bone marrow aspirate
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.

Intervention: Procedure: bone marrow aspirate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3
December 2015
December 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age between 18 and 70 years
  • Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head
  • Stadiums <IIIC ARCO ranking

Exclusion Criteria:

  • Those on investigator judgment not in a good position to tolerate the procedure.
  • Clinical criteria and anesthetics that contraindicate surgery (eg ASA IV-V)
  • Serious illness uncontrolled
  • Pregnant women
  • Patients with HIV infection +
  • Acute infection (in the previous 15 days) or chronic (other than HIV)
  • Previous treatments of osteonecrosis
  • Active or previous neoplastic disease (last 5 years) except for patients undergoing allogeneic haematopoietic progenitors who are in complete remission after 2 years after transplantation.
  • Lack of informed consent or revocation thereof.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01700920
CSM/ON/2011
Yes
Not Provided
Not Provided
Red de Terapia Celular
Red de Terapia Celular
  • Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
  • Spanish National Health System
Not Provided
Red de Terapia Celular
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP
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