SMG-SNU Boramae Hospital
Seoul, South Korea
NCT Number: NCT01300598
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 1 / Phase 2
Seoul, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intra-articular infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e7 cells/3mL,5x10e7 cells/3mL, 1x10e8 cells/3mL
Other names: RNL-JointStem®
Time frame: 24 weeks
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
Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score.
Time frame: 24 weeks
Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist.
Time frame: 24 weeks
Changes in exercise score and function of joint evaluation by KSCRS(Knee Society Clinical rating System).
Time frame: 24 weeks
Changes in VAS(11-point box visual analogue scale) score.
Time frame: 24 weeks
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
changes of the cartilage volume of the knee joint measure using a semi-automated segmentation method by a blinded researcher (webappendix)
Time frame: 24 weeks
Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 6 months after injection
Time frame: 24 weeks
X-ray perform to measure with Kellgren-Lawrence grade,20 joint space width of the medial compartment,21 mechanical axis with weight bearing line,22 and anatomical axis.
R-Bio
Industry
Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
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