Phase
Condition
Osteoarthritis
Treatment
Placebo Control
JointStem
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
<Inclusion Criteria>
Male or female of any race, adult aged 18 years or older
Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria)
Subject who has ≥ 45 on WOMAC function score at Screening and Baseline
Subject who has knee pain ≥ 70 mm for the study knee out of 100 mm on VAS (Visual Analog Scale) at Screening and Baseline
Subject who has radiographic evidence of grade 3 osteoarthritis in the study knee based on the Kellgren and Lawrence radiographic criteria
Subject who has a varus angle of 5 degrees or less confirmed through radiography
Subjects whose knee pain persists for at least 12 weeks (about 3 months) prior to Screening and does not improve symptoms with non-operative treatment options
Subject who is willing to discontinue all pain medications for osteoarthritis except rescue medication (acetaminophen < 3.25 g per day) at least 72 hours prior to Screening and throughout the duration of study
Subject who is willing and able to give written informed consent for participation in the study
<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(s) (i.e., uncontrolled comorbid disease, kidney diseases, liver diseases, endocrine diseases, etc., but not limited to these diseases) that may affect the patient's participation in the study.
Subject who has any of following clinically significant diseases:
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 and/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 has 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 has 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 has 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):
Serum ALT and AST > 2 x upper limit of normal
Serum creatinine out of normal range
PT/INR out of normal range
Hemoglobin < 10 g/dL for female subject and hemoglobin < 11 g/dL for male subject
Platelets out of normal range
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
Study Design
Study Description
Connect with a study center
Keimyung University Dongsan Hospital
Daegu, Korea Republic of, 42601
Korea, Republic ofActive - Recruiting
Kyung Hee University Hospital At Gangdong
Seoul, Korea Republic of, 05278
Korea, Republic ofActive - Recruiting
Kyung Hee University Medical Center
Seoul, Korea Republic of, 02447
Korea, Republic ofActive - Recruiting
Smg-Snu Boramae Medical Center
Seoul, Korea Republic of, 07061
Korea, Republic ofActive - Recruiting
TriWest Research Associates
El Cajon, California 92020
United StatesActive - Recruiting
BioSolutions Clinical Research Center
La Mesa, California 91942
United StatesActive - Recruiting
Neurovations Research
Napa, California 94558
United StatesActive - Recruiting
Newport Therapeutics
Newport Beach, California 92660
United StatesActive - Recruiting
Source Healthcare
Santa Monica, California 90403
United StatesActive - Recruiting
International Spine Pain, and Performance Center
Washington, District of Columbia 20006
United StatesSite Not Available
Rothman Orthopaedic Institute
Egg Harbor Township, New Jersey 08234
United StatesSite Not Available
Hospital for Special Surgery
New York, New York 10021
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.