Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus (NCT04310215) | Clinical Trial Compass
CompletedPhase 3
Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus
South Korea102 participantsStarted 2020-03-03
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of adding CARTISTEM®(allogenic umbilical cord blood-derived stem cell product) on microfracture, a currently standard treatment for OLT, in patients with talar chondral or osteochondral defect.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Talar chondral/osteochondral lesion confirmed by radiographical exam at screening or diagnosis, an AOFAS score of 75 or below
✓. Ankle joint pain/stiffness with no response to conservative treatment for more than 12 weeks
✓. Ankle joint cartilage injury of defect of ICRS grade Ⅳ in MRI
✓. Male or female aged more than 18
✓. A one-sided lesion
✓. Appropriate function of blood clot: PT(INR) \< 1.5×ULN, aPTT \<1.5×ULN
✕. Degenerative arthritis in ankle(Kellgren Lawrence Grade 3-4)
✕. Autoimmune disease
✕. Infectious disease need to administration of parenteral antibiotics
✕. Myocardial infarction, congestive heart failure, other serious cardiac disorder or uncontrolled resistant hypertension
✕. Serious medical disease(Ex. Kidney disease such as chronic renal failure or Glomerulonephritis, etc., acute/chronic liver disease such as liver cirrhosis, fatty liver etc., medical history of malignancy\*)