E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteonecrosis of the femur head |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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, |
|
E.2.2 | Secondary objectives of the trial |
To determine hip survival at 6 months following treatment with either autologous TRC with core decompression or core decompression alone. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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) <2.5 X institutional standards range. • Serum creatinine within normal limits, based on clinical laboratory normal range, or creatinine clearance (calculated) ≥60 mL/min, if serum creatinine is outside of normal range.
|
|
E.4 | Principal exclusion criteria |
Subjects <18 and >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)
|
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end point of the trial in this case is where the effects of the tissue grafting will be completed. The last visit for a treatment or control subject is intended to allow the collection of safety and economic data for the study. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 30 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 30 |