The purpose of this study is to confirm cartilage regeneration through arthroscopy after a single administration of autologous Adipose Tissue derived Mesenchymal stem cells(JOINTSTEM) in patients with degenerative arthritis of K-L grade 3
JOINTSTEM is injectables for an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is cultured without additional genetic modification, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection. It primarily aims to regenerate cartilage. The intra-articular injection of JOINTSTEM is expected to stimulate the regeneration of cartilage, and to innovatively improve joint function with cartilage regeneration. The subjects of this therapy were patients with K\&L grade 3 aged 20 or older. This study is a double-blind, randomized, placebo controlled study with two arms to evaluate JOINTSTEM as a treatment for subjects with osteoarthritis. Following a 2-week screening period, approximately 21 patients will be randomly assigned into one of the following two arms in a 2:1 ratio (2 JointStem : 1 placebo control). After each patient completes 12-month visit (Visit 6) and the data management team confirms all data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
Bethesda Hospital
Yangsan, South Korea
Arthroscopy
Change of damaged cartilage defects after 48 weeks from IP administration, compared to Baseline (Experimental group vs Control group)
Time frame: 48 Weeks
WOMAC total score
Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) total scores from baseline (Experimental group vs Control group)
Time frame: 12 weeks, 24 weeks, 48 weeks
WOMAC subscale score
Change of Western Ontario and McMaster Universities (WOMAC) subscale score (3 sub-scales: Pain, stiffness, and physical function of the knee) from baseline (Experimental group vs Control group)
Time frame: 12 weeks, 24 weeks, 48 weeks
VAS score
Change of Visual Analog Scale (VAS) from baseline (Experimental group vs Control group) Pain of knee will be measured by the 100mm VAS Score range is from 0mm(no pain) to 100mm(severe pain) Pain of knee will be measured by the 100mm Visual Analog Scale (VAS)
Time frame: 12 weeks, 24 weeks, 48 weeks
RAND-36
Change of The RAND-36 Measure of Health-Related Quality of Life (RAND-36) score from baseline (Experimental group vs Control group) Scoring the RAND 36-Item Health Survey is a two-step process. First, precoded numeric values are recoded per the scoring key given in Table 1. Note that all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores.
Time frame: 12 weeks, 24 weeks, 48 weeks
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IKDC
Change of International Knee Documentation Committee (IKDC) score from baseline (Experimental group vs Control group) The IKDC is a patient-completed tool, which contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time frame: 12 weeks, 24 weeks, 48 weeks
Biopsy
Change of Biopsy from baseline (Experimental group vs Control group)
Time frame: 48 Weeks
Use of rescue medication
Frequency and total amount of rescue medication administration will be measured.
Time frame: 4 Weeks, 12 Weeks, 24 Weeks, 48 Weeks
Kellgren-Lawrence grade
Change from baseline in Kellgren-Lawrence grade of knee osteoarthritis determined by X-ray at Week 48
Time frame: 24 Weeks, 48 Weeks