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UNKNOWNPHASE3

Phase 3 Clinical Trial of CartiLife® in Korea

A Multi-Center, Active-Controlled, Open-Label, Phase III Trial to Compare the Efficacy and Safety for Treatment of Autologous Chondrocytes Implantation With CartiLife Versus Microfracture for Patients With Knee Chondral Defects

NCT05051332•Biosolution Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating costal chondrocytes of the subject implanted into articular cartilage defects of the knee resulting from trauma or degeneration.

Detailed Description

This open-label, phase 3 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) compared with microfracture surgery in adults with articular cartilage defects due to trauma or degeneration of the knee. It is hypothesized that CartiLife® treatment will demonstrate structural regeneration and improvement in function and pain at Week 48 compared to baseline.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•In order to be eligible to participate in this study, an individual must meet all of the following:
•1. Patients over the age of 18.
•2. Defect size: 2 to 10 cm\^2 on the unilateral knee cartilage (up to 4 ㎤ in volume).
•3. Defect: isolated ICRS (International Cartilage Repair Society) grade III or IV single defect chondral lesion on articular cartilage with comparatively healthy cartilage present near the lesion site (ICRS Grade 1 \~ 2).
•4. Patients with a KOOS total score below 55.
•5. Patients able to walk without aid.
•6. Patients who agree to abide by rehabilitation protocols and follow-up programs, including residential exercise routines.
•7. Patients who provide written consent to the application of the clinical trial.

Exclusion Criteria

•Individuals who meet any of the following will be excluded from participation in this study:
•1. Patients with inflammatory articular diseases such as rheumatoid arthritis or gouty arthritis.
•2. Patients scoring 3 or above on the Kellgren-Lawrence Grading Scale.
•3. Patients with inflammatory articular diseases related to autoimmune diseases.
•4. Patients hypersensitive to bovine derived proteins or any of the components in this product.
•5. Patients hypersensitive to Gentamycin.
•6. Patients with Haemophilia or markedly reduced immune function.
•7. Patients with arterial bleeding and severe venous bleeding.
•8. Patients with other diseases including tumors except for cartilaginous defects of joints.
•9. Patients with a history of radiation treatment and chemotherapy within the past two years.
+3 more criteria

Locations (18)

Inje University Haeundae Paik Hospital

Busan, South Korea

Kosin University Gospel Hospital

Busan, South Korea

Chungnam National University Hospital

Daejeon, South Korea

Chonnam National University Hwasun Hospital

Gwangju, South Korea

Chosun University Hospital

Gwangju, South Korea

Pusan National University Hospital

Pusan, South Korea

Seoul National University Bundang Hospital (1)

Seongnam-si, South Korea

Seoul National University Bundang Hospital (2)

Seongnam-si, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

March 19, 2020

Primary Completion Date

September 30, 2023

Completion Date

September 30, 2024

Last Updated

May 17, 2022

Enrollment

104

ESTIMATED participants

Conditions

Articular Cartilage DefectArticular Cartilage Degeneration

Interventions

Autologous Chondrocyte Implantation (CartiLife®)

DRUG

Microfracture Surgery

PROCEDURE

A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle

NCT06915233

Chondral DefectArticular Cartilage Defect

View study

RECRUITINGNA

A Comparison of JointRep® and Microfracture in Repair of Cartilage Lesions on the Femoral Condyle or Trochlea,

NCT04840147

Chondral DefectArticular Cartilage Defect+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 17, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 3 Clinical Trial of CartiLife® in Korea

Inclusion Criteria

Exclusion Criteria

A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle

A Comparison of JointRep® and Microfracture in Repair of Cartilage Lesions on the Femoral Condyle or Trochlea,

Study Comparing Two Methods for the Treatment of Large Chondral and Osteochondral Defects of the Knee

Phase III Study to Evaluate Safety and Effectiveness of NOVOCART 3D Plus vs. Microfracture in Knee Cartilage Defects

Phase 2 Clinical Trial of CartiLife® in the United States

Confirmatory Study of NeoCart in Knee Cartilage Repair