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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CartiLife® | Experimental | Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Chondrocyte Implantation (CartiLife®) | Drug | CartiLife consists of small beads (1 mm in diameter) in suspension, developed from pellet culture of autologous costal chondrocytes after multiplication. The beads are implanted in an injective manner with fibrin glue through minimal arthrotomy. The dose depends on the size (volume) of the defect, recommended dose is 480 pellets/cm^3 defect |
| Measure | Description | Time Frame |
|---|---|---|
| Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) function (sports and recreational activities) | The KOOS (Knee Injury and Osteoarthritis Outcome Score) is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011). The score ranges from 0 to 100, with 0 representing extreme problems and 100 representing no problems. | Week 0 (pre-operation) to Week 48 (post-operation) |
| Change in volume fill of cartilage defect score | Volume fill of cartilage defect score from MOCART 2.0 Criteria (Schreiner, et al, 2019). The score is from 0 to 20, with 0 representing "<25% filling of total defect volume OR complete delamination in situ" and 20 representing "Complete fill OR minor hypertrophy (100% to 150% filling of total defect volume). | Week 0 (pre-operation) to Week 48 (post-operation) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Lysholm Score | The Lysholm scale is a broadly applicable, validated tool for measuring changes following nonsurgical and surgical intervention, as well as deterioration over time in patients with various knee pathologies (Collins et al, 2011). The score is from 0 to 100, with 0 representing extreme problems and 100 representing no problems. | Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation) |
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Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following:
Exclusion Criteria:
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):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TaeKyung Kim, MA | Contact | +82234468884 | 6683 | taekyung1215@biosolutions.co.kr |
| Jungsun Lee, Ph.D | Contact | +82234468884 | 6603 | dvmljs@biosolutions.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jungsun Lee, Ph.D | Biosolution Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tilda Research | Not yet recruiting | Irvine | California | 92612 | United States |
No plan to share IPD at this point.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 21, 2026 | May 11, 2026 | 5 |
Investigational group: CartiLife® Extracellular matrix-associated autologous chondrocytes comprise CartiLife®, composed as pellets (1.1 to 1.8 mm in diameter) in suspension. One pre-filled syringe is implanted per 1 cm3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy.
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| Change in IKDC (International Knee Documentation Committee) Score | The IKDC (International Knee Documentation Committee) Knee form covers domains likely to be important to patients and has adequate consistency and broad applicability across mixed groups of patients (Collins et al, 2011). The score is from 0 to 100, with 0 representing extreme problems and 100 representing no problems. | Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation) |
| Change in KOOS (Knee injury Osteoarthritis Outcome Score) subscale scores (Pain, Other symptoms, Function in daily living, and knee-related Quality of Life) | The KOOS (Knee injury Osteoarthritis Outcome Score) is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011). The score is from 0 to 100, with 0 representing extreme problems and 100 representing no problems. | Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation) |
| Change in KOOS (Knee injury Osteoarthritis Outcome Score) Total Score | The KOOS is a reliable and valid patient-reported outcome measurement tool that evaluates both short-term and long-term consequences of knee injury. The 5 separately scored subscales of Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related QOL may enrich clinical and research data interpretation (Roos and Lohmander, 2003; Collins et al, 2011). The score is from 0 to 100, with 0 representing extreme problems and 100 representing no problems. | Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation) |
| Change in VAS (100mm Pain Visual Analogue Scale) | The VAS is a validated, ubiquitous tool for patient-reported measurement of pain at a given point in time (Kersten et al, 2014). The score is from 0 to 100, with 0 representing no pain and 100 representing extreme pain. | Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation) |
| Change in Tegner Activity Score | The Tegner activity score is a frequently used patient-administered activity rating system for patients with various knee activity functions. The instrument scores a person's activity level between 0 and 10 where 0 is 'on sick leave/disability' and 10 is 'participation in competitive sports such as soccer at a national or international elite level' (Karen Hambly, 2011). | Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation) |
| Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Score | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints (Jose M. 2006). The score is from 0 to 100, with 0 representing no problems and 100 representing extreme problems. | Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation) |
| Evaluations of MOCART Score | MOCART provides a reliable, reproducible, and accurate method of assessment of cartilage repair tissue. The total score is determined by adding the following subscale scores :
| Week 24 and 48 (post-operation) |
| Evaluation of T2 mapping | In vivo, the visualization of collagen architecture, and possibly the maturation of this architecture over time in cartilage repair tissue, can be seen when assessing the spatial variation of T2 values. Histologically validated animal studies report this increase in zonal T2 as an indicator of hyaline or ''hyaline-like'' cartilage composition. T2 evaluation is more sensitive in revealing changes in articular cartilage and cartilage repair tissue compared to morphological analysis using thickness measurements or the MOCART score. (Mamisch et al, 2010) | Week 24 and 48 (post-operation) |
| Change in pain medication dosage | Pain medication history is an indicator of patient pain. The amount of analgesic ingestion is measured for the specified duration over the course of the clinical trial, and changes in analgesic ingestion are assessed to analyze the efficacy of the clinical trial product. | Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation) |
| Change in pain medication frequency | Pain medication history is an indicator of patient pain. The frequency of analgesic ingestion is measured for the specified duration over the course of the clinical trial, and changes in analgesic ingestion in terms of frequency are assessed to analyze the efficacy of the clinical trial product. | Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation) |
| Number of subjects with treatment-related adverse events | Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, and abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results | Week 0 (pre-operation), and up to 24 Months (post-operation) |
| Number of subjects with treatment-emergent serious adverse events | Number of subjects with treatment-emergent serious adverse events defined as one or more of the following untoward medical occurrences happening during study period.
| Week 0 (pre-operation), and up to 24 Months (post-operation) |
| Biosolutions Clinical Research Center | Recruiting | La Mesa | California | 91942 | United States |
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| Horizon Clinical Research | Recruiting | La Mesa | California | 91942 | United States |
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| Lafayette General Health | Recruiting | Lafayette | Louisiana | 70506 | United States |
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| Ohio State University | Recruiting | Columbus | Ohio | 43210 | United States |
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