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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)

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ClinicalTrials.gov Identifier: NCT01700920
Recruitment Status : Completed
First Posted : October 4, 2012
Last Update Posted : March 30, 2017
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteonecrosis of the Femoral Head Procedure: bone marrow aspirate Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteonecrosis

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Spain
University Hospital of Salamanca
Salamanca, Castilla y León, Spain, 37007
Sponsors and Collaborators
Red de Terapia Celular
Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
Spanish National Health System
More Information
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Additional Information:

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Responsible Party: Red de Terapia Celular
ClinicalTrials.gov Identifier: NCT01700920    
Other Study ID Numbers: CSM/ON/2011
First Posted: October 4, 2012    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Keywords provided by Red de Terapia Celular:
Osteonecrosis of the femoral head
Stem Cell
Mesenchymal Stem Cells
Femoral Head
Additional relevant MeSH terms:
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Osteonecrosis
Legg-Calve-Perthes Disease
Bone Diseases
Musculoskeletal Diseases
 Necrosis
Pathologic Processes
Femur Head Necrosis