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Phase 2 Clinical Trial of CartiLife® in the United States | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Phase 2 Clinical Trial of CartiLife® in the United States

A Multi-Center, Open-Label, Phase 2 Trial to Evaluate the Efficacy and Safety of CartiLife® for Patients With Articular Cartilage Defects in the Knee

NCT04744402•Biosolution Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the safety and efficacy of implanting pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) obtained by cultivating costal chondrocytes of the subject with articular cartilage defects of the knee as a result of trauma or degeneration.

Detailed Description

This open-label, phase 2 study is being conducted to evaluate the safety and efficacy of pellet-type extracellular matrix-associated autologous chondrocytes (CartiLife®) 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 - No limit 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. Male or female subjects aged over 18 at the time of signing the Informed Consent form
•2. Subject who has a size of the relevant cartilage lesion ≥ 2 cm2 and ≤ 10 cm2 but with a defect area total volume ≤ 4 cm3
•3. Subject with isolated International Cartilage Repair Society (ICRS) Grade III or IV chondral lesion on articular cartilage
•4. Subject who has a lower extremity alignment within 5 degrees of the neutral weight bearing axis
•5. Subject who can move independently and has a mechanically stable knee (normal ligament status)
•6. Subject with intact or partial meniscus status (\>50% of meniscus)
•7. Subject who has KOOS pain value less than 60 at baseline
•8. Subject who agrees to actively participate in a rehabilitation protocol and follow-up program
•9. Subject who is able to provide informed consent and comply with study requirements
+3 more criteria

Exclusion Criteria

•Individuals who meet any of the following will be excluded from participation in this study:
•1. Subject who has inflammatory articular diseases such as rheumatoid arthritis or gout or pseudogout
•2. Subject who has radiographic evidence of grade 4 osteoarthritis based on the Kellgren and Lawrence criteria
•3. Subject who has received an intra-articular treatment within the last 3 months
•4. Subject who has had a surgical procedure on the knees within the last 6 weeks (Subjects can be considered enrollment per the investigator's discretion)
•5. Subject who has a condition in another lower extremity joint that interferes with the function of the index knee
•6. Subject who would receive a concomitant surgical procedure on the knees at the time of the study treatment
•7. Subject whose articular cartilage defect is asymptomatic
•8. Subject who has any clinically significant disease, which is judged by the investigator to affect this clinical trial, including but not limited to diabetes not adequately controlled, bleeding diathesis or hematologic disease, endocrinopathies, cardiovascular disease, renal disease (severe renal impairment), autoimmune disease, inflammatory arthritis, and current infectious disease
•9. Subject with other diseases including tumors except for cartilaginous defects of joints
+15 more criteria

Locations (5)

Tilda Research

Irvine, California, United States

Biosolutions Clinical Research Center

La Mesa, California, United States

Horizon Clinical Research

La Mesa, California, United States

Lafayette General Health

Lafayette, Louisiana, United States

Ohio State University

Columbus, Ohio, United States

Key Dates

Start Date

October 28, 2020

Primary Completion Date

December 1, 2023

Completion Date

December 1, 2023

Last Updated

August 28, 2023

Enrollment

ESTIMATED participants

Conditions

Articular Cartilage DefectArticular Cartilage Degeneration

Interventions

Autologous Chondrocyte Implantation (CartiLife®)

DRUG

Contacts

TaeKyung Kim, MA

CONTACT

+82234468884 taekyung1215@biosolutions.co.kr

Jungsun Lee, Ph.D

CONTACT

+82234468884 dvmljs@biosolutions.co.kr

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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: August 28, 2023Data 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.

View ClinicalTrials.gov Terms and Conditions

Phase 2 Clinical Trial of CartiLife® in the United States

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

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Phase 3 Clinical Trial of CartiLife® in Korea

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