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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Adipose Tissue derived MSCs Transplantation | Procedure | Intra-articular infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e7 cells/3mL,5x10e7 cells/3mL, 1x10e8 cells/3mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging | Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist. | 24 weeks |
| KSCRS(Knee Society Clinical rating System) | Changes in exercise score and function of joint evaluation by KSCRS(Knee Society Clinical rating System). |
| Measure | Description | Time Frame |
|---|---|---|
| cartilage volume of the knee joint | changes of the cartilage volume of the knee joint measure using a semi-automated segmentation method by a blinded researcher (webappendix) | 24 weeks |
| Arthroscopy | Arthroscopy performs to evaluate any change in cartilage defect at the time of cell injection, and at 6 months after injection |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kang Sup Yoon, M.D. & Ph.D. | SMG-SNU Boramae Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SMG-SNU Boramae Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24449146 | Result | Jo CH, Lee YG, Shin WH, Kim H, Chai JW, Jeong EC, Kim JE, Shim H, Shin JS, Shin IS, Ra JC, Oh S, Yoon KS. Intra-articular injection of mesenchymal stem cells for the treatment of osteoarthritis of the knee: a proof-of-concept clinical trial. Stem Cells. 2014 May;32(5):1254-66. doi: 10.1002/stem.1634. | |
| 28746812 | Result |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 24 weeks |
| VAS(11-point box visual analogue scale) | Changes in VAS(11-point box visual analogue scale) score. | 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. | 24 weeks |
| 24 weeks |
| X-ray | 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. | 24 weeks |
| Jo CH, Chai JW, Jeong EC, Oh S, Shin JS, Shim H, Yoon KS. Intra-articular Injection of Mesenchymal Stem Cells for the Treatment of Osteoarthritis of the Knee: A 2-Year Follow-up Study. Am J Sports Med. 2017 Oct;45(12):2774-2783. doi: 10.1177/0363546517716641. Epub 2017 Jul 26. |