Multi-center, Multi-national Clinical Trial of the Application of Tissue Repair Cell (TRC) Therapy of Osteonecrosis in the Femur Head

• Conditions: Osteonecrosis of the femur head

• Registration Number: EUCTR2006-001286-42-ES
• Lead Sponsor: Aastrom Biosciences, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-05-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 15

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified