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

NCT04310215 | Completed Phase 3

• 1 other identifier: CARTISTEM_2019_01
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 6

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

Keywords

OLT; Talus; Chondral Lesion; Osteochondral Lesion; Human umbilical cord blood-derived stem cell; MSC; Mesenchymal stem cell

Outcome Measures

Primary Outcomes (1)

• ICRS-Cartilage Repair Assessment Total Score

  Arthroscopic evaluation of articular cartilage repair : The score range from 12(normal) to 1(severely abnormal) where lower scores indicate more severity of injury

  Week 48

Secondary Outcomes (7)

• 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

Study Arms (2)

Microfracture + CARTISTEM®

EXPERIMENTAL

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

Biological: CARTISTEM®

Microfracture

ACTIVE COMPARATOR

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

Procedure: Microfracture

Interventions

CARTISTEM® 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 + CARTISTEM®

Microfracture PROCEDURE

\*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠ 1\. Procedure: Microfracture

Microfracture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hyundai Bioland Co., Ltd.: lead
• Medipost Co Ltd.: collaborator

Study Sites (6)

Kyunghee University Medical Center

Seoul, Dongdaemun-gu, 02447, South Korea

Location

Gangnam Severance Hospital

Seoul, Gangnam-gu, 06273, South Korea

Location

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

Location

Korea University Guro Hospital

Seoul, Guro-gu, 08308, South Korea

Location

Chungnam National University Hospital

Daejeon, Jung-gu, 35015, South Korea

Location

Inha University Hospital

Incheon, Jung-gu, 22332, South Korea

Location

MeSH Terms

Interventions

Arthroplasty, Subchondral

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter, Single-blinded, Stratified randomized

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 17, 2020
• Study Start: March 3, 2020
• Primary Completion: June 13, 2022
• Study Completion: June 13, 2022
• Last Updated: November 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)