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 is currently recruiting participants.

Verified October 2012 by Red de Terapia Celular

Sponsor:

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

ClinicalTrials.gov Identifier:

NCT01700920

First received: October 2, 2012

Last updated: NA

Last verified: October 2012

History: No changes posted

Tracking Information
First Received Date ^ICMJE	October 2, 2012
Last Updated Date	October 2, 2012
Start Date ^ICMJE	July 2012
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
Official Title ^ICMJE	PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Osteonecrosis of the Femoral Head
Intervention ^ICMJE	Procedure: bone marrow aspirate
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Enrollment ^ICMJE	10
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01700920
Other Study ID Numbers ^ICMJE	CSM/ON/2011
Has Data Monitoring Committee	Yes
Responsible Party	Red de Terapia Celular
Study Sponsor ^ICMJE	Red de Terapia Celular
Collaborators ^ICMJE	Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán Spanish National Health System
Investigators ^ICMJE	Not Provided
Information Provided By	Red de Terapia Celular
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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