The purpose of this study is to determine whether CARTISTEM, a cell therapeutic product, is
safe and effective in the treatment of articular cartilage defects of the knee as a result of
ageing, trauma, or degenerative diseases.
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Locations near you
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Full eligibility criteria for NCT01733186
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
Patients with an intended- to- treat single focal, full-thickness cartilage defect
(ICRS [International Cartilage Repair Society] Grade 3 or 4) of the knee as a result of ageing, trauma, or degenerative diseases.
Age ≥ 18 years old
Size of the articular cartilage lesion is ≥ 2 cm2
Swelling, tenderness and active range of motion ≤ Grade II
Joint pain : 20-mm - 60-mm on VAS (Visual Analog Scale) at the time of Screening
Appropriate blood coagulation, kidney and liver function laboratory parameters: PT(INR) < 1.5, APTT <1.5×control Creatinine ≤ 2.0 mg/dL Albumin ≤ trace in urine dipstick test Bilirubin ≤ 2.0 mg/dL, AST/ALT ≤ 100 IU/L
Ligament instability ≤ Grade II
Lower extremity alignment within 5 degrees of the neutral weight bearing axis
No meniscal surgery within the past 3 months and more than 5mm of meniscal rim remaining
Ability and willingness to fully participate in the post-operative rehabilitation program
Subject is informed of the investigational nature of this study, voluntarily agrees to participate in the study, and signs an IRBapproved informed consent prior to performing any of the screening procedures
Body Mass Index (BMI) ≤ 35 kg/m2
Patients who have been treated previously and are asymptomatic
Avascular necrosis/ osteonecrosis
Autoimmune or inflammatory joint disease
History of infection within the past 6 weeks
Surgery or radiation therapy within the past 6 weeks
Serious medical co-morbidities, which would otherwise contraindicate surgery, as determined by the investigator
Currently pregnant or nursing
Psychotic diseases, epilepsy, or any history of such diseases
Current abuse of alcohol (> 10 drinks weekly) and/or regular exposure to other substances of abuse, currently an active smoker
Chronic inflammatory articular diseases such as rheumatoid arthritis
Enrolled in any other clinical trials within the past 4 weeks
Administered immunosuppressants such as Cyclosporin A or azathioprine within the past 6 weeks
Corticosteroid or viscosupplementation injection to the affected knee in the past 3 months
Principal investigator considers inappropriate for the clinical trial due to any reasons other than those listed above
All locations for NCT01733186
United States (2)
Cartilage Restoration Center; RUSH University Medical Center
Chicago, Illinois, United States, 60612
Cartilage Repair Center; Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
View full eligibility
Tris trial is registered with FDA with number: NCT01733186. The sponsor of the trial is Medipost Co Ltd. and it is looking for 12 volunteers for the current phase.
Official trial title: Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects: A Phase I/IIa Clinical Trial in Patients With Focal, Full-thickness Grade 3-4 Articular Cartilage Defects of the Knee
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