Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
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
Appropriate renal function: Creatinine ≤ 2.0 ㎎/㎗, Proteinuria ≤ trace
Appropriate hepatic function: Total bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
No evidence of auto-immune disorder: According to investigator's judgement based on relevent symtom and physical exam, anti-nuclear antibody and anti-thyroglobulin antibody tests are able to performed and confirmed negative (If positive, there are possible cases according to diagnostic opinion of medical department)
No surgery or radiotherapy for the same ankle joint within 6 weeks
Female patients agreeing with maintenance of contraception* during study period
*hormone contraceptive, implants of intrauterine device or intrauterine system, double barrier contraception[Concurrent use of diaphragm or cervical occlusive cap and male condom], surgical sterilisation, etc.
No chronic ligament instability more than grade Ⅲ (Grade 0: none, Grade Ⅰ: 1~5㎜, GradeⅡ: 5~10㎜, Grade Ⅲ: >10㎜)
Patients agreeing with participation in this study and signed on informed consent by their own will
Exclusion criteria
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*)
*Complete remission status is possible.
Pregnancy or breast-feeding
Psychiatric history or epilepsy
Alcohol abuse
Heavy smoker
Chronic inflammatory disease such as rheumatoid arthritis
Participants other clinical trials within 4 weeks
Administration of immunosuppressing agents such as Cyclosporin A or azathioprine within 6 weeks
Patients with acute ligament injury and clinically significant chronic ligament instability
Patients treated with surgery or cell therapy product for the same disease
Patients with hypersensitivity or allergy history to bovine protein, hyaluronic acid and gentamicin
Other inappropriate patients determined by the principal investigator
Primary purpose
Allocation
Interventional model
Masking
102 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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