PHASE II CLINICAL TRIAL Prospective, Open, Nonrandomized Treatment of Osteonecrosis of the Femoral Head by the Administration of Autologous Mesenchymal Stem Cells
NCT ID: NCT01700920
Last Updated: 2017-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
3 participants
INTERVENTIONAL
2012-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
bone marrow aspirate
Interventions
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bone marrow aspirate
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis and imaging (Rx and NMR) of idiopathic osteonecrosis of the femoral head
* Stadiums \<IIIC ARCO ranking
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán
OTHER
Spanish National Health System
OTHER
Red de Terapia Celular
INDUSTRY
Responsible Party
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Locations
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University Hospital of Salamanca
Salamanca, Castille and León, Spain
Countries
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Related Links
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Spanish cell therapy network (TerCel)
Salamanca University Foundation
Spanish Health Institute Carlos III
Other Identifiers
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CSM/ON/2011
Identifier Type: -
Identifier Source: org_study_id
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