Status:
COMPLETED
Evaluate the Effect of Bone Marrow Derived Cd133+ Cells in Patient With Osteonecrosis of Femoral Head
Lead Sponsor:
Royan Institute
Conditions:
Osteonecrosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Avascular necrosis is a disease where there is cellular death (necrosis) of bone components due to interruption of the blood supply. Without blood, the bone tissue dies and the bone collapses. If avas...
Detailed Description
A vascular necrosis of femoral head is a debilitating disease resulting from interruption of blood supply to the bone. This pathologic process results in the death of marrow and osteocytes and, in its...
Eligibility Criteria
Inclusion
- Upenn (Steinberg) classification of osteonecrosis, inclusive of Stages IIB and IIC. Diagnosis will be based on magnetic resonance imaging (MRI).
- Modified index of necrotic extent \< 40
- Idiopathic and non-idiopathic osteonecrosis.
- No infection in affected bones at the time of surgery.
- Patient competent to give informed consent.
- Normal organ and marrow function defined as:
- Leukocytes ≥ 3000/µL;
- Absolute neutrophil count ≥ 1500/µL;
- Platelets ≥ 140,000/µL;
- Serum AST (SGOT)/ALT (SGPT) \< 2.5 X institutional standard range;
- Serum creatinine within normal limits, based on clinical laboratory normal range.
- Female patients not pregnant or lactating.
- Patients with a history of corticosteroids or on active therapy, will only be eligible for enrollment if corticosteroid use is suspended for 1 month prior and 6 months after cell therapy and surgery.
- Patients who have been treated with oral bisphosphonates are eligible for the trial if treatment was stopped at least 6 months prior to enrollment.
Exclusion
- Stages IA, IB, IC, IIA, IIIA or more severe femoral head osteonecrosis, primarily based on diagnosis by MRI.
- Flattening of the femur head (UPenn Stage IV) or articular cartilage collapse at the time of core decompression surgery.
- Septic arthritis; stress fracture, or non-osteonecrosis metabolic bone diseases (e.g., Paget's disease of bone, osteogenesis imperfecta, primary hyperparathyroidism, fibrous dysplasia \[monostotic, polyostotic McCune-Albright syndrome\] and osteopetrosis).
- Any active bisphosphonate treatment or any history of intravenous (IV) treatment
- HIV, syphilis, positive at time of screening.
- Active hepatitis B or hepatitis C infection at the time of screening
- Known allergies to protein products (horse or bovine serum, or porcine trypsin).
- Patients who will require continuous, systemic, high dose corticosteroid therapy (more than 7.5 mg/day) within 6 months after surgery.
- received chemotherapy, radiotherapy or immunotherapy in the past 2 years.
- Immunodeficiency diseases.
- Participation in another clinical study in the past 30 days or concurrent participation in another clinical trial.
- History of regular alcohol consumption exceeding 2 drinks/day (1 drink = 5 oz \[150 mL\] of wine or 12 oz \[360 mL\] of beer or 1.5 oz \[45 mL\] of hard liquor) within 6 months of screening and/or history of illicit drug use.
- MRI-incompatible internal devices (pacemakers, aneurysm clips, etc)
- Body mass index (BMI) of 40 Kg/m2 or greater
- Patients unable to tolerate general anesthesia defined as an American Society of Anesthesiologists (ASA) criteria of \> 2
- Patients with poorly controlled diabetes mellitus (HbA1C \> 8%), or with peripheral neuropathy, or known concomitant vascular problems.
- Patients receiving treatment with hematopoietic growth factors or anti-vasculogenesis or anti-angiogenesis treatment
- Traumatic osteonecrosis
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01198080
Start Date
August 1 2009
End Date
June 1 2013
Last Update
August 28 2013
Active Locations (1)
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1
Royan Institute
Tehran, Iran