NCT04310215CompletedPhase 3
A Multi-center, Single-blind, Randomized, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Adding CARTISTEM® on Microfracture in Patients With Talar Chondral or Osteochondral Defect
Hyundai Bioland Co., Ltd.12 sites in 1 country102 target enrollmentStarted: March 3, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Hyundai Bioland Co., Ltd.
- Enrollment
- 102
- Locations
- 12
- Primary Endpoint
- ICRS-Cartilage Repair Assessment Total Score
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
ICRS-Cartilage Repair Assessment Total Score
Time Frame: Week 48
Arthroscopic evaluation of articular cartilage repair : The score range from 12(normal) to 1(severely abnormal) where lower scores indicate more severity of injury
Secondary Outcomes
- ICRS-Cartilage Repair Assessment Overall Grade(Week 48)
- Improvement degree of Cartilage Repair by MRI(Week 0 and 48)
- Degree of Functional improvement in FAOS(Foot & Ankle Outcome Score)(Week 0, 24 and 48)
- Degree of Functional improvement in AOFAS(The American Orthopaedic Foot & Ankle Score)(Week 0, 24 and 48)
- Degree of Functional improvement in Tegner activity score(Week 0, 24 and 48)
- Degree of Quality of Life improvement in SF-36(Short Form Health Survey-36)(Week 0, 24 and 48)
- Degree of pain improvement in 100 mm VAS(Visual Analogue Scale)(Week 0, 24 and 48)
Investigators
Study Sites (12)
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