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
Objective: Safety and efficacy assessment (such as quality of life and hip joint condition improvement and pain relief) of bone marrow derived CD133+ cell transplantation in patients with avascular necrosis of femoral head.
Design: An intervention clinical trial phase I, not blinded, non randomized, uni-center in patients with avascular necrosis of femoral head. Sample size: Ten patients.
Setting and conduct: Patients with osteonecrosis of the femoral head who visited in orthopedics clinic of Royan cell therapy center, would transplant autologous bone marrow derived CD133+ cells during core decompression surgery and they will follow at 2, 6 and 12 months after injection.
Participants: Patients in a range of 18 to 65 years old, with femoral head osteonecrosis who are candidates for core decompression, and not suffered from other chronic diseases, viral disorders and cancer.
Interventions: Implantation of autologous bone marrow derived CD133 possesses cells with core decompression procedure. Primary outcome: Safety of bone marrow derived CD133+ cell transplantation
Secondary outcome: Efficacy assessment (such as quality of life and hip joint condition improvement and pain relief) of bone marrow derived CD133+ cell transplantation
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507231031N3
Registration date:2016-10-06, 1395/07/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-06, 1395/07/15
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2013-05-22, 1392/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Transplantation of bone marrow cells in patients with femoral head osteonecrosis
Purpose
Treatment
Inclusion/Exclusion criteria
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