The purpose is to assess the safety and feasibility of cellular therapy derived from bone marrow, to help bone healing in patients with avascular necrosis of the hip.
To assess the safety and feasibility of an in situ single injection of a high dose of autologous bone marrow-derived, in vitro expanded Mesenchymal stem cells, and its contribution to the resolution of the early stages of avascular osteonecrosis of the femoral head.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Cultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control.
Department of Orthopaedic Surgery, Hôpital Henri Mondor
Créteil, France
Department of Orthopaedic Surgery, CHU Tours
Tours, France
University Children's Hospital
Tübingen, Germany
Department of Orthopaedic Trauma, University of Ulm
Ulm, Germany
Complication rate
Includes early local complication rate plus global complication rate, as the percentage of patients with local or general complications at 52 weeks.
Time frame: 12 months
complication rate
Local and general complication rate
Time frame: 6,12,24,104 weeks
Progression of disease to the next stage
Time frame: 12 months
Amount of necrotic bone in the femoral head in MRI
Time frame: 12 weeks and 52 weeks
Pain (VAS)
Time frame: 6,12,24,52,104 weeks
serum levels of bone turnover markers
Time frame: 12 and 24 weeks
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Istituto Ortopedico Rizzoli
Bologna, Italy
Servicio de Cirugía Ortopédica y Traumatología "A", Hospital La Paz
Madrid, Spain