Osteonecrosis of the femur head
Conditions
Interventions
Product Name: Tissue Repair Cells
Pharmaceutical Form: Implant
INN or Proposed INN: AUTOLOGOUS BONE MARROW CELLS
Concentration type: range
Concentration number: 100 MILLION CELLS-160 million cells
Sponsors
Aastrom Biosciences, Inc
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: U Penn (Steinberg)(1) classification of osteonecrosis, inclusive of Grades IIA, IIB, IIC, IIIA, IIIB, and IIIC. Diagnosis will be based on MRI and plane radiographs (5 standard views for femur head osteonecrosis). Gender: Male. Age: 18 - 60 years Subjects taking, or with history of taking prescription statins, bisphosphonates or blood pressure lowering drugs may be included. Idiopathic and non-idiopathic Osteonecrosis. No infection in affected bones. Patient competent to give informed consent. Serum 25(OH)D at 20-50 ng/ml (or within normal range) prior to entry into study. Cessation of smoking at least 3 months prior to enrollment. Normal organ and marrow function as defined: • Leukocytes =3000/µL • Absolute neutrophil count =1500/µL • Platelets =140,000/µL • Serum AST (SGOT)/ALT (SGPT) =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects 60 years Grade IA, IB, IC, IVA or more severe femoral head osteonecrosis, primarily based on diagnosis by MRI. Flattening of the femur head (U Penn Stage IV) or articular cartilage collapse at the time of core decompression surgery. Transient osteoporosis of the hip; transient bone marrow edema syndrome; septic arthritis; stress fracture, or metabolic bone disease. Active infection in affected bones Sickle cell anemia HIV, Hepatitis B or C positive or syphilis. Known allergies to gentamicin and/or vancomycin, protein products (horse or bovine serum, or porcine trypsin) used in the ex vivo TRC production process. Patients who will require continued, systemic, high dose corticosteroid therapy (>7.5mg/day) after surgery. Patients in active treatment for cancer or who have received cancer chemotherapy or irradiation therapy in past 10 years. Immunodeficiency diseases. Concurrent participation in another clinical trial. Alcoholics not in treatment and still drinking (14+ drinks/week) MRI-incompatible internal devices (pacemakers, aneurysm clips, etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if Aastrom's autologous Tissue Repair Cells (TRC) tissue grafting after core decompression surgery safely eliminates or delays progression of osteonecrosis more often than core decompression alone, at 6 months after treatment,;Secondary Objective: To determine hip survival at 6 months following treatment with either autologous TRC with core decompression or core decompression alone.;Primary end point(s): Eliminating or delaying progression of osteonecrosis, as evidenced by reduction in baseline percent MRI- detected- osteonecrosis volume of the femur head, at 6 months after therapy. | — |
Countries
Spain
Outcome results
None listed