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About
This study is a double-blind, randomized, placebo controlled, multi-center, superiority study to evaluate the efficacy and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed as knee osteoarthritis. Following a 2-week screening period, approximately 140 subjects will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 Placebo). After each subject completes 48-Weeks visit (Visit 8) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
Full description
Study Procedures:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Subject who has Body Mass Index (BMI) > 35 kg/m2
Subject judged by the investigator to have a history of clinically significant disease
Subject who has any of following clinically significant disease
Autoimmune diseases
Paget's disease, ochronosis, acromegaly, hemochromatosis, or Wilson's disease
Genetic diseases (hyperkinesia, collagen gene abnormality, etc.)
Inflammatory joint disorders (e.g. rheumatoid inflammation)
Infectious joint disorders (e.g. septic arthritis)
Other joint disorders (e.g. gout, recurrent pseudogout, articular fracture, primary osteochondrosis, villonodular synovitis)
Subject who has any history of cancer or currently receiving treatment for a current cancer diagnosis
Subject who is positive in pathogenic test (HIV, viral hepatitis, or syphilis)
Subject who has heart diseases (myocardial infarction, coronary artery bypass graft surgery, arrhythmia, or other serious heart diseases) or has history of heart diseases within 6 months prior to Screening
Subject who have received any intra-articular therapy in any joint within 6 months prior to Screening, or surgery on the relevant knee including articular endoscopic procedures within 6 months prior to Screening
Subject who has history of prolotherapy, or platelet rich plasma injection within 6 months prior to Screening
Subject who have received long-acting hyaluronic acid injection (e.g. Synvisc-One®, etc.) within 6 months prior to Screening
Subject who has history of stem cell therapy
Subject who have significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment):
Subject for whom the investigator judges the lipoaspiration can cause any problem
Subject who has history of local anesthetic allergy
Subject who has taken anti-inflammatory drugs (prescription and non-prescription NSAIDs), symptomatic slow acting drugs (glucosamine, chondroitin sulfate, diacerhein etc.), or oral steroids (prednisone etc.) within 14 days prior to Screening (however, those who undergo a 14-day wash-out period can participate.)
Subject who is an active drug/alcohol abuser
Pregnant or breast-feeding women, or women or men who are not using appropriate method of contraception (appropriate method includes hormones, bilateral tubal ligation, and barrier method with spermicide, and intra-uterine device for women and vasectomy and barrier method with spermicide for men; subjects should agree to use appropriate method)
Subject who is enrolled in any other clinical trials within 3 months from Screening
Subject who received the COVID-19 vaccines within 1 week from Visit 2 (Lipoaspiration, baseline)
Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above
Primary purpose
Allocation
Interventional model
Masking
140 participants in 2 patient groups, including a placebo group
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Central trial contact
Hugh Lee; Christine Lee
Data sourced from clinicaltrials.gov
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