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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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2012 by Red de Terapia Celular.
Recruitment status was  Recruiting
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

October 2, 2012
October 2, 2012
July 2012
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No Changes Posted
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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
10
Not Provided
Not Provided

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.
Both
18 Years to 70 Years
No
Spain
 
NCT01700920
CSM/ON/2011
Yes
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
October 2012

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