The purpose of this study is to investigate the efficacy and safety of autologous transplantation of Adipose Tissue derived Mesenchymal stem cells (MSCs) in patient with avascular necrosis of the femoral head.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Into the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL
SMG-SNU Boramae Medical Center
Seoul, South Korea
Magnetic Resonance Imaging
To evaluate the change of treated femoral head using Magnetic Resonance Imaging (MRI) at 24 months post injection of MSCs.
Time frame: 96 weeks
SPECT/CT
To evaluate the change of treated femoral head using SPEC/CT at 24 months post injection of MSCs.
Time frame: 96 weeks
Hip X-ray
To confirm the collapse of femoral head using Hip X-ray at 24 months post injection of MSCs.
Time frame: 96 weeks
HHS (Harris Hip Score)
To evaluate the change of treated femoral head using Harris Hip Score at 24 months post injection of MSCs.
Time frame: 96 weeks
WOMAC (Western Ontario and McMaster Universities) Index
To evaluate the change of treated femoral head using WOMAC Index at 24 months post injection of MSCs.
Time frame: 96 weeks
UCLA (University of California Los Angeles) hip questionnaire
To evaluate the change of treated femoral head using UCLA hip questionnaire at 24 months post injection of MSCs.
Time frame: 96 weeks
Safety evaluation
To determine the overall safety of Autologous Adipose Tissue Derived Mesenchymal Stem Cells carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests.
Time frame: 96 weeks
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