Multi-center, Randomized, Double-Blind, Placebo Controlled Phase 3 Clinical Trial to Evaluate Efficacy and Safty of Mesenchymal Stem Cells JointStem in Patients With Knee Osteoarthritis
Overview
- Phase
- Phase 3
- Intervention
- JOINTSTEM
- Conditions
- Degenerative Arthritis
- Sponsor
- R-Bio
- Enrollment
- 260
- Locations
- 13
- Primary Endpoint
- Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to investigate the efficacy and safety of autologous Adipose Tissue derived Mesenchymal stem cells (JOINTSTEM®) in patient with severe Knee Osteoarthritis.
Detailed Description
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 improve joint function. 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 260 patients will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 placebo control). After each patient completes 6-month visit (Visit 5) 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 20 and older, male and female
- •Patients must consent in writing to participate in the study by signing and dating an informed consent document
- •Diagnosis of degenerative arthritis of class 1-3 by ACR(American College of Rheumatology Criteria) Global functional criteria
- •Diagnosis of Kellgren and Lawrence grade 3 by radiographic criteria
- •Patients suitable for one of three conditions of 'diagnostic criteria for osteoarthritis of knee' based on ACR guideline
- •clinical and inspectional opinion
- •clinical and radiographic opinion
- •clinical opinion
- •Patients who has joint pain ≥ 50mm on 100mm VAS (Visual Analog Scale) at Screening
- •Patient who has WOMAC score ≥ 1000 at Screening
Exclusion Criteria
- •Patients who have pregnancy plans within this trial period or childbearing age patients who do not agree to maintain contraception status through appropriate contraception methods
- •Appropriate contraception method: Use of condom, contraceptive sponges, foam, diaphragm, intrauterine device etc.
- •Periodic abstinence(e.g. methods of predicting ovulation) and moderation are not considered as appropriate contraception method.
- •Not allowed to use hormonal contraceptives
- •Childbearing age female patients, exclude menopausal female (amenorrhea for more than 24 months after the last menstruation) or female who has no possibility of pregnency by surgical sterilization operation, can participate in this study only determined negative in pregnancy test
- •Pregnant women or lactating mothers
- •Patients with Body Mass Index (BMI) \> 35
- •Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection
- •Patients with other disease including
- •Septic arthritis, Rheumatoid or Inflammatory joint disease, Gout, Reccurent pseudogout, Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease,Osteochondromatosis, Hereditary disorder, Genetic disorder of collagen
Arms & Interventions
JOINTSTEM
Autologous Adipose Tissue derived MSCs
Intervention: JOINTSTEM
saline
saline
Intervention: saline
Outcomes
Primary Outcomes
Change of Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) scores from baseline
Time Frame: 12 weeks, 24 weeks
Pain, stiffness, and physical function of the knee will be measured by the WOMAC score * Score range is 1. 0-20 for Pain 2. 0-8 for Stiffness 3. 0-68 for Pysical Function * Higher scores on the WOMAC indicate wors pain, stiffness, and functional limitations
Change of Visual Analog Scale (VAS) scores from baseline
Time Frame: 12 weeks, 24 weeks
Pain of knee will be measured by the 100mm VAS -Score range is from 0-4mm(no pain) to 75-100mm(severe pain)
Secondary Outcomes
- KOOS(12 weeks, 24 weeks)
- WOMAC 3 subscale score(12 weeks, 24 weeks)
- SF-36(12 weeks, 24 weeks)
- VAS score(12 weeks, 24 weeks)
- IKDC(12weeks, 24 weeks)
- Measuring of Kellgren-Lawrence grade(12 weeks, 24 weeks)
- Measuring of Femoro-tibial anatomical angle(FTA)(12 weeks, 24 weeks)
- Measuring of Hip-Knee-Ankle angle(HKA)(12 weeks, 24 weeks)
- Measuring of Joint Space Width(12 weeks, 24 weeks)
- MRI scan(12 weeks, 24 weeks)
- Use of rescue medication(12 weeks, 24 weeks)