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Tests treatment safety and results for Osteoarthritis, Knee
Official title A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis
ClinicalTrials.gov ID: NCT04368806
What this study is testing
What is JointStem?
JointStem is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for osteoarthritis, knee.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- 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.)
See the full eligibility 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
- people 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 \<
- 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...
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- El Cajon, California, United States
- La Mesa, California, United States
- Napa, California, United States
- Newport Beach, California, United States
- Santa Monica, California, United States
- Daegu, Korea, South Korea
- Seoul, Korea, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include El Cajon, California, United States; La Mesa, California, United States; Napa, California, United States; Newport Beach, California, United States; Santa Monica, California, United States; Daegu, Korea, South Korea and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.