A Phase 1/2 interventional study of Autologous Adipose Tissue derived MSCs Transplantation in Degenerative Arthritis, sponsored by R-Bio. Completed at 1 site in South Korea. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-06-05.
Sponsored by R-Bio · Phase 1/2, Interventional, and Treatment
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.
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 18 is below the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →R-Bio is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Intra-articular infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e7 cells/3mL,5x10e7 cells/3mL, 1x10e8 cells/3mL
Also known as: RNL-JointStem®
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
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)
Time frame: 24 weeks
Arthroscopy
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
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.
Time frame: 24 weeks
The record gives a start of Dec 2008, a primary completion of Sep 2011 and a completion of Mar 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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