RECRUITING

Phase 2 Clinical Trial of CartiLife® in the United States

Conditions

Articular Cartilage Defect Articular Cartilage Degeneration

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-10-28

Study Completion:2023-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04744402

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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 10. Subject who is willing to discontinue any nonsteroidal anti-inflammatory drugs (NSAIDs) except rescue medication (\< acetaminophen 4 g per day) 7 days prior to visit 11. Subject who has Body Mass Index (BMI) ≤ 37 kg/m2 12. Female and male subjects of childbearing potential who are willing to use adequate contraception methods for the duration of the trial.	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 10. Subject who has a history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin 11. Subject who participates in concurrent trials or in previous trial within 30 days of signing informed consent 12. Subject who has any radiation therapy or chemotherapy within 2 years prior to screening 13. Subject who is currently pregnant or nursing 14. Subject who has any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures. 15. Subject with known HIV infection, active hepatitis C and/or hepatitis B infection 16. Subject who has ligament instability \> Grade 1 17. Subject who is an active drug/alcohol abuser or has a history of alcohol or drug abuse during the last two years. 18. Subject who has significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment): * Serum ALT and AST \> 3 x upper limit of normal * Serum creatinine \> 1.5 x upper limit of normal * PT/INR out of normal range * Hemoglobin \< 10 g/dL for female subject and hemoglobin \< 11 g/dL for male subject * Platelets out of normal range * Hemoglobin A1c levels \> 9%

Inclusion Criteria

Exclusion Criteria

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
10. Subject who is willing to discontinue any nonsteroidal anti-inflammatory drugs (NSAIDs) except rescue medication (\< acetaminophen 4 g per day) 7 days prior to visit
11. Subject who has Body Mass Index (BMI) ≤ 37 kg/m2
12. Female and male subjects of childbearing potential who are willing to use adequate contraception methods for the duration of the trial.

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
10. Subject who has a history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
11. Subject who participates in concurrent trials or in previous trial within 30 days of signing informed consent
12. Subject who has any radiation therapy or chemotherapy within 2 years prior to screening
13. Subject who is currently pregnant or nursing
14. Subject who has any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.
15. Subject with known HIV infection, active hepatitis C and/or hepatitis B infection
16. Subject who has ligament instability \> Grade 1
17. Subject who is an active drug/alcohol abuser or has a history of alcohol or drug abuse during the last two years.
18. Subject who has significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment):
* Serum ALT and AST \> 3 x upper limit of normal
* Serum creatinine \> 1.5 x upper limit of normal
* PT/INR out of normal range
* Hemoglobin \< 10 g/dL for female subject and hemoglobin \< 11 g/dL for male subject
* Platelets out of normal range
* Hemoglobin A1c levels \> 9%

Contacts and Locations

Study Contact

TaeKyung Kim, MA

CONTACT

+82234468884

taekyung1215@biosolutions.co.kr

Jungsun Lee, Ph.D

CONTACT

+82234468884

dvmljs@biosolutions.co.kr

Principal Investigator

Jungsun Lee, Ph.D

STUDY_DIRECTOR

Biosolution Co., Ltd.

Study Locations (Sites)

Tilda Research

Irvine, California, 92612

United States

Biosolutions Clinical Research Center

La Mesa, California, 91942

United States

Horizon Clinical Research

La Mesa, California, 91942

United States

Lafayette General Health

Lafayette, Louisiana, 70506

United States

Ohio State University

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Biosolution Co., Ltd.

Jungsun Lee, Ph.D, STUDY_DIRECTOR, Biosolution Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-28

Study Completion Date2023-12

Study Record Updates

Study Start Date2020-10-28

Study Completion Date2023-12

Terms related to this study

Additional Relevant MeSH Terms

Articular Cartilage Defect
Articular Cartilage Degeneration