Phase 2 Clinical Trial of CartiLife® in the United States

Recruiting now · Phase 2

Conditions studied: Articular Cartilage Defect, Articular Cartilage Degeneration

In brief

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.

Key facts

Study ID: NCT04744402
Run by: Biosolution Co., Ltd.
People needed: 25
Starts: 2020-10-28
Expected to finish: 2023-12-01
Last updated by the study team: 2023-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

In order to be eligible to participate in this study, an individual must meet all of the following:
Male or female subjects aged over 18 at the time of signing the Informed Consent form
Subject who has a size of the relevant cartilage lesion ≥ 2 cm2 and ≤ 10 cm2 but with a defect area total volume ≤ 4 cm3
Subject with isolated International Cartilage Repair Society (ICRS) Grade III or IV chondral lesion on articular cartilage
Subject who has a lower extremity alignment within 5 degrees of the neutral weight bearing axis
Subject who can move independently and has a mechanically stable knee (normal ligament status)
Subject with intact or partial meniscus status (>50% of meniscus)
Subject who has KOOS pain value less than 60 at baseline
Subject who agrees to actively participate in a rehabilitation protocol and follow-up program
Subject who is able to provide informed consent and comply with study requirements
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
Subject who has Body Mass Index (BMI) ≤ 37 kg/m2
Female and male subjects of childbearing potential who are willing to use adequate contraception methods for the duration of the trial.

You may not qualify if…

Individuals who meet any of the following will be excluded from participation in this study:
Subject who has inflammatory articular diseases such as rheumatoid arthritis or gout or pseudogout
Subject who has radiographic evidence of grade 4 osteoarthritis based on the Kellgren and Lawrence criteria
Subject who has received an intra-articular treatment within the last 3 months
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)
Subject who has a condition in another lower extremity joint that interferes with the function of the index knee
Subject who would receive a concomitant surgical procedure on the knees at the time of the study treatment
Subject whose articular cartilage defect is asymptomatic
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
Subject with other diseases including tumors except for cartilaginous defects of joints
Subject who has a history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
Subject who participates in concurrent trials or in previous trial within 30 days of signing informed consent
Subject who has any radiation therapy or chemotherapy within 2 years prior to screening
Subject who is currently pregnant or nursing
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.
Subject with known HIV infection, active hepatitis C and/or hepatitis B infection
Subject who has ligament instability > Grade 1
Subject who is an active drug/alcohol abuser or has a history of alcohol or drug abuse during the last two years.
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%

Where it is running

Biosolutions Clinical Research Center — La Mesa, California, United States (enrolling)
Horizon Clinical Research — La Mesa, California, United States (enrolling)
Lafayette General Health — Lafayette, Louisiana, United States (enrolling)
Ohio State University — Columbus, Ohio, United States (enrolling)
Tilda Research — Irvine, California, United States

Full record on ClinicalTrials.gov

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