Status:
COMPLETED
Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus
Lead Sponsor:
Hyundai Bioland Co., Ltd.
Collaborating Sponsors:
Medipost Co Ltd.
Conditions:
Chondral or Osteochondral Lesion of Talus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2022
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04310215
Start Date
March 3 2020
End Date
June 13 2022
Last Update
November 29 2022
Active Locations (6)
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1
Kyunghee University Medical Center
Seoul, Dongdaemun-gu, South Korea, 02447
2
Gangnam Severance Hospital
Seoul, Gangnam-gu, South Korea, 06273
3
Samsung Medical Center
Seoul, Gangnam-gu, South Korea, 06351
4
Korea University Guro Hospital
Seoul, Guro-gu, South Korea, 08308