Efficacy and Safety of Allogenic Stem Cell Product(CARTISTEM®) for Osteochondral Lesion of Talus

NCT ID: NCT04310215

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-03
• Study Completion Date: 2022-06-13

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.

Conditions

Chondral or Osteochondral Lesion of Talus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Microfracture + CARTISTEM®

CARTISTEM® is added on the lesion as a single dose of 500 ㎕/㎠ according to the defect size after arthroscopic curettage and microfracture.

Group Type: EXPERIMENTAL

CARTISTEM®

Intervention Type: BIOLOGICAL

*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠

1. Procedure: Microfracture

2. Biological: CARTISTEM®(Human Umbilical Cord Blood-derived Mesenchymal Stem Cell product)

Microfracture

Standard treatment of arthroscopic curettage and microfracture is performed for cartilage defect.

Group Type: ACTIVE_COMPARATOR

Microfracture

Intervention Type: PROCEDURE

*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠

1. Procedure: Microfracture

Interventions

CARTISTEM®

*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠

1. Procedure: Microfracture

2. Biological: CARTISTEM®(Human Umbilical Cord Blood-derived Mesenchymal Stem Cell product)

Intervention Type: BIOLOGICAL

Microfracture

*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠

1. Procedure: Microfracture

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipost Co Ltd.

INDUSTRY

Sponsor Role: collaborator

Hyundai Bioland Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Kyunghee University Medical Center

Seoul, Dongdaemun-gu, South Korea

Gangnam Severance Hospital

Seoul, Gangnam-gu, South Korea

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Korea University Guro Hospital

Seoul, Guro-gu, South Korea

Chungnam National University Hospital

Daejeon, Jung-gu, South Korea

Inha University Hospital

Incheon, Jung-gu, South Korea

Countries

South Korea

Other Identifiers

CARTISTEM_2019_01

Identifier Type: -

Identifier Source: org_study_id