A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Kne… (NCT04368806) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis
United States, South Korea173 participantsStarted 2021-05-26
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in a combined Phase 2b/3a stage — what does that mean for how much we already know about JointStem's safety and effectiveness compared to treatments that are already fully approved for knee osteoarthritis?
2The trial is no longer enrolling new patients — does that mean the results might be available soon, and could those results change what treatment options you'd recommend for me right now?
3The study measures pain and physical function using the WOMAC and VAS scales — based on where my scores fall on those scales today, do you think I would have been a good candidate for this kind of trial, and what does that tell us about the severity of my condition?
4JointStem appears to be a stem cell-based therapy — what are the specific risks I should understand about that type of treatment compared to more established options like injections, physical therapy, or surgery for my knee osteoarthritis?
5Since I can't enroll in this trial now that it's closed, are there other active trials or newer treatments targeting knee osteoarthritis that you think would be worth looking into given my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score
. 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
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:
. 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