Clinical trial NCT04310215: Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chondral or Osteochondral Lesion of Talus
Keywords: OLT
Talus
Chondral Lesion
Osteochondral Lesion
Human umbilical cord blood-derived stem cell
MSC
Mesenchymal stem cell
Lead sponsor: Hyundai Bioland Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Medipost Co Ltd.
First posted: 2020-03-17
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A multicenter, Single-blinded, Stratified randomized
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Talar chondral/osteochondral lesion confirmed by radiographical exam at screening or diagnosis, an AOFAS score of 75 or below
2. Ankle joint pain/stiffness with no response to conservative treatment for more than 12 weeks
3. Ankle joint cartilage injury of defect of ICRS grade Ⅳ in MRI
4. Male or female aged more than 18
5. A one-sided lesion
6. Appropriate function of blood clot: PT(INR) \< 1.5×ULN, aPTT \<1.5×ULN
7. Appropriate renal function: Creatinine ≤ 2.0 ㎎/㎗, Proteinuria ≤ trace
8. Appropriate hepatic function: Total bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L
9. 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)
10. No surgery or radiotherapy for the same ankle joint within 6 weeks
11. 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.
12. No chronic ligament instability more than grade Ⅲ (Grade 0: none, Grade Ⅰ: 1\~5㎜, GradeⅡ: 5\~10㎜, Grade Ⅲ: \>10㎜)
13. Patients agreeing with participation in this study and signed on informed consent by their own will

Exclusion Criteria:

1. Degenerative arthritis in ankle(Kellgren Lawrence Grade 3-4)
2. Autoimmune disease
3. Infectious disease need to administration of parenteral antibiotics
4. Myocardial infarction, congestive heart failure, other serious cardiac disorder or uncontrolled resistant hypertension
5. 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.
6. Pregnancy or breast-feeding
7. Psychiatric history or epilepsy
8. Alcohol abuse
9. Heavy smoker
10. Chronic inflammatory disease such as rheumatoid arthritis
11. Participants other clinical trials within 4 weeks
12. Administration of immunosuppressing agents such as Cyclosporin A or azathioprine within 6 weeks
13. Patients with acute ligament injury and clinically significant chronic ligament instability
14. Patients treated with surgery or cell therapy product for the same disease
15. Patients with hypersensitivity or allergy history to bovine protein, hyaluronic acid and gentamicin
16. Other inappropriate patients determined by the principal investigator

Primary outcomes:
measure: ICRS-Cartilage Repair Assessment Total Score
timeFrame: Week 48
Secondary outcomes:
measure: ICRS-Cartilage Repair Assessment Overall Grade
timeFrame: Week 48
measure: Improvement degree of Cartilage Repair by MRI
timeFrame: Week 0 and 48
measure: Degree of Functional improvement in FAOS(Foot & Ankle Outcome Score)
timeFrame: Week 0, 24 and 48
measure: Degree of Functional improvement in AOFAS(The American Orthopaedic Foot & Ankle Score)
timeFrame: Week 0, 24 and 48
measure: Degree of Functional improvement in Tegner activity score
timeFrame: Week 0, 24 and 48
measure: Degree of Quality of Life improvement in SF-36(Short Form Health Survey-36)
timeFrame: Week 0, 24 and 48
measure: Degree of pain improvement in 100 mm VAS(Visual Analogue Scale)
timeFrame: Week 0, 24 and 48
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
state: Dongdaemun-gu
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
state: Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Guro-gu
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
state: Jung-gu
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
state: Jung-gu
Study officials:
References: