Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis
|Degenerative Arthritis||Procedure: Autologous Adipose Tissue derived MSCs Transplantation||Phase 1 Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy of Autologous Adipose Tissue Derived Mesenchymal Stem Cells Transplantation in Patient With Degenerative Arthritis|
- Safety evaluation [ 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.
- WOMAC(Western Ontario and McMaster Universities) Index [ Time Frame: 24 weeks ]Pain as measured by the The Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Score.
- Magnetic Resonance Imaging [ Time Frame: 24 weeks ]Changes in the MRI knee with cartilage mapping and clinical improvement assessed by radiologist.
- KSCRS(Knee Society Clinical rating System) [ Time Frame: 24 weeks ]Changes in exercise score and function of joint evaluation by KSCRS(Knee Society Clinical rating System).
- VAS(11-point box visual analogue scale) [ Time Frame: 24 weeks ]Changes in VAS(11-point box visual analogue scale) score.
- Histological evaluates [ 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.
- cartilage volume of the knee joint [ 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)
- Arthroscopy [ 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
- X-ray [ 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.
|Study Start Date:||December 2008|
|Study Completion Date:||March 2012|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
Procedure: Autologous Adipose Tissue derived MSCs Transplantation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300598
|Korea, Republic of|
|SMG-SNU Boramae Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Kang Sup Yoon, M.D. & Ph.D.||SMG-SNU Boramae Hospital|