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IRCT201507231031N3 IRCT 2016-10-06 Royan Institute Transplantation of bone marrow cells in patients with femoral head osteonecrosis Evaluation of safety and feasibility of bone marrow-derived CD133 cells possesses transplantation in patients with the femoral head Osteonecrosis (AVN) -An interventional clinical trial phase I 2009-07-23 anticipated 10 Complete https://irct.ir/trial/28 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1 Osteonecrosis of the femoral head, unspecified. Intervention group: bone marrow derived CD133+ cells injection with core compression.
public Shahedeh Karimi Torshizi
Royan institute, Eastern Hafez St, Northern Banihashem St, 45 m Resalat highway
Tehran Iran (Islamic Republic of) +98 21 2251 8388 karimi58shah@gmail.com Royan Institute scientific Nasser Aghdami
Royan Institute, Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
Tehran Iran (Islamic Republic of) +98 21 2356 2000 nasser.aghdami@royaninstitute.org Royan cell Therapy Center Iran (Islamic Republic of) Inclusion Criteria: Upenn (Steinberg) classification of osteonecrosis, inclusive of Stages IIB and IIC that 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 Criteria: Femoral head osteonecrosis' Stages IA, IB, IC, IIA, IIIA or more severe, primarily based on diagnosis by MRI; Flattening of the femur head (UPenn Stage IV) or articular cartilage collapse while 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 18 years 65 years Both M87.9 Osteonecrosis, unspecified Other Intervention group: bone marrow derived CD133+ cells injection with core compression Safety of bone marrow derived CD133+ cells transplantation. Timepoint: 1, 3, 6 and 12 months after transplantation. Method of measurement: MRI, Physical function, side effects. Quality of life. Timepoint: Before injection, 6 and 12 months after injection. Method of measurement: SF-36 Questionnaire. Hip articular change. Timepoint: Before injection, 6 and 12 months after injection. Method of measurement: Standard WOMAC, VAS and HHS questionnaires. Side effects. Timepoint: Before injection, 6, 12 and 24 months after injection. Method of measurement: Side effects questionnaire. NCT01198080 clinicaltrials.gov Royan Institute Approved 2011-05-10 Ethics committee of Royan infertility institute Eastern Hafez St,Northern Banihashem St, Resalat highway 45 meters Tehran Iran (Islamic Republic of)