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 degenerative arthritis.
degenerative arthritis is the most common type of arthritis. It is estimated that 26.9 million Americans 25 years old or older have clinical degenerative arthritis of some joints, with a higher percentage of affliction in the older population. Its clinical manifestations include joint pain and impairment to movement, and surrounding tissues are often affected with local inflammation. The etiology of degenerative arthritis is not completely understood; however, injury, age, and genetics have been considered among the risk factors. Degenerative arthritis is a progressively debilitating disease that affects mostly cartilage, with associated changes in bone. Cartilage has limited intrinsic healing and regenerative capacities. Due to the increasing incidence of degenerative arthritis and the aging population coupled with inefficient therapeutic choices, novel cartilage repair strategies are in need. The availability of large quantities of MSCs and their potential for ready chondrogenic differentiation after prolonged in vitro expansion have made MSCs the most hopeful candidate progenitor cell source for cartilage tissue engineering. In the clinical study, mesenchymal stem cells will be isolated from adipose tissue and cultured, and administered into the cartilage tissue lesion by orthopedic surgery. It will be stimulate the regeneration of defective cartilage tissue and to improve their functions.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Intra-articular infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e7 cells/3mL,5x10e7 cells/3mL, 1x10e8 cells/3mL
SMG-SNU Boramae Hospital
Seoul, South Korea
Safety evaluation
To determine the overall safety of RNL-JointStem® carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests.
Time frame: 24 weeks
WOMAC(Western Ontario and McMaster Universities) Index
Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score.
Time frame: 24 weeks
Magnetic Resonance Imaging
Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist.
Time frame: 24 weeks
KSCRS(Knee Society Clinical rating System)
Changes in exercise score and function of joint evaluation by KSCRS(Knee Society Clinical rating System).
Time frame: 24 weeks
VAS(11-point box visual analogue scale)
Changes in VAS(11-point box visual analogue scale) score.
Time frame: 24 weeks
Histological evaluates
Biopsy specimens subject to safranin-O staining and immunohistochemistry for type I and II collagen. Thickness of the articular cartilage before and after injection measure, and specimens evaluate with ICRS II by a blind histopathologist.
Time frame: 24 weeks
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