Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular… (NCT01733186) | Clinical Trial Compass
CompletedPhase 1/2
Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects
United States12 participantsStarted 2013-01-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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:
* 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
Exclusion Criteria:
* 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 medic…