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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.
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.
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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 cm^3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy. |
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| Microfracture Surgery | Active Comparator | Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate. |
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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 |
|---|---|---|
| MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) | MOCART is a validated tool that provides reliable, reproducible, and accurate assessment of cartilage repair tissue (Marlovits et al, 2006 that; Trattnig et al, 2011). | At Week 48, post-operation |
| KOOS 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). In the 'Knee injury and Osteoarthritis Outcome Score', scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. | From Week 0 to Week 48, post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| MOCART Score | MOCART is a validated tool that provides reliable, reproducible, and accurate assessment of cartilage repair tissue (Marlovits et al, 2006 that; Trattnig et al, 2011). In the 'Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score', the total score ranges from 0 to 100, with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Jungsun Lee, Ph.D | Biosolution Co., Ltd. | Study Director |
| Kyoung Ho Yoon, MD | Kyung Hee University Hospital | Principal Investigator |
| Jae Doo Yoo, MD | Ewha Womans University Mokdong Hospital | Principal Investigator |
| Sang Hak Lee, MD | Kyung Hee University Hospital at Gangdong | Principal Investigator |
| Sung-Hwan Kim, MD | Gangnam Severance Hospital | Principal Investigator |
| Ji Hoon Bae, MD | Korea University Guro Hospital | Principal Investigator |
| Hyuk-Soo Han, MD | Seoul National University Hospital | Principal Investigator |
| Joon Ho Wang, MD | Samsung Medical Center | Principal Investigator |
| Min Jung, MD | Severance Hospital | Principal Investigator |
| Yong In, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea | |||
| Kosin University Gospel Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32125878 | Background | Yoon KH, Park JY, Lee JY, Lee E, Lee J, Kim SG. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation for Treatment of Articular Cartilage Defect. Am J Sports Med. 2020 Apr;48(5):1236-1245. doi: 10.1177/0363546520905565. Epub 2020 Mar 3. | |
| 32476445 | Background | Yoon KH, Yoo JD, Choi CH, Lee J, Lee JY, Kim SG, Park JY. Costal Chondrocyte-Derived Pellet-Type Autologous Chondrocyte Implantation versus Microfracture for Repair of Articular Cartilage Defects: A Prospective Randomized Trial. Cartilage. 2021 Dec;13(1_suppl):1092S-1104S. doi: 10.1177/1947603520921448. Epub 2020 Jun 1. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| NCT03545269 | Clinical Study Report | View IPD |
There are no future plans to share the IPD at this time.
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Investigational Group : CartiLife® Procedure: 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 cm^3 of defect volume, and fibrin adhesive is applied to fix pellets in place through minimal arthrotomy.
Active comparator: Microfracture Surgery Procedure : Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate.
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| Microfracture Surgery | Procedure | Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate |
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| At Week 24 and Week 96, post-operation |
| 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). In the 'Lysholm score', the total score ranges from 0 to 100, with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. | At Week 0 to Week 8, 24, 48 and 96, post-operation |
| IKDC Score | The IKDC 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). In the 'International Knee Documentation Committee Subjective Knee Form', the total score ranges from 0 to 100, with a score of 0 indicating the worst knee symptoms(lowest level of function or highest level of symptoms) and 100 indicating no knee symptoms(highest level of function and lowest level of symptoms). | At Week 0 to Week 8, 24, 48 and 96, post-operation |
| KOOS Score (Pain, Other symptoms, Function in daily living, Function in sport and recreation, and knee-related QOL subscales) | 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). KOOS Score (Pain, Other symptoms, Function in daily living, Function in sport and recreation, and knee-related QOL subscales) are measured between 0, 1, 2, 3 and 4. The KOOS subscales are scored separately: Pain (9 items); Symptoms (7 items); Function in daily living (17 items); Function in sport and recreation (5 items); knee-related QOL (4 items). Each scale is scored between 0 to 4. The total score ranges from 0 to 100, with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. | At Week 0 to Week 8, 24, 48 and 96, post-operation |
| 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). Visual Analogue Scale (VAS) is a measurement instrument that measures a specified characteristic which is deemed difficult to quantify across a continuous line of value to determine its representative value. The VAS scale ranges from 0 to 100 mm, with 0 indicating absence of pain and 100 indicating the worst pain experienced. | At Week 0 to Week 8, 24, 48 and 96, post-operation |
| Tegner Activity Scale | 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). A level of 0 indicates that the patient is unable to participate in activities barring 'Sick leave or disability pension because of knee problems', and a level of 10 indicates that the patient is capable of participating in activities which at its most intense include 'Competitive sports - soccer, football, rugby at a national elite level'. | At Week 0 to Week 8, 24, 48 and 96, post-operation |
| Pain medication history | Pain medication history is an indicator of patient pain. 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. | At Week 0 to Week 8, 24, 48 and 96, post-operation |
| Treatment related adverse events | Number of subjects with treatment related adverse events as assessed by analysis of adverse events including symptoms, abnormal findings on physical examination, vital signs, ECG, and standard laboratory examination results. The total number of patients who exhibit symptoms identified as an adverse event will be cumulatively combined to obtain a whole digit number representing the number of patients who have suffered an adverse event throughout the course of the clinical trial. | At Week 0 (pre-operation), and up to 24 Months (post-operation) |
| The Catholic UNIV. of Korea Seoul St. Mary's Hospital |
| Principal Investigator |
| Chong Bum Chang, MD | Seoul National University Bundang Hospital (1) | Principal Investigator |
| Yong Seuk Lee, MD | Seoul National University Bundang Hospital (2) | Principal Investigator |
| Seok Jung Kim, MD | The Catholic UNIV. of Korea Uijeongbu St. Mary's Hospital | Principal Investigator |
| Jong Geun Seon, MD | Chonnam National University Hospital | Principal Investigator |
| Dong Hwi Kim, MD | Chosun University Hospital | Principal Investigator |
| Young-Mo Kim, MD | Chungnam National University Hospital | Principal Investigator |
| Seung Joon Rhee, MD | Pusan National University Hospital | Principal Investigator |
| Sang Won Moon, MD | Haeundae Paik Hospital, Inje University | Principal Investigator |
| Young Choi, MD | Kosin University Gospel Hospital | Principal Investigator |
| Busan |
| 49267 |
| South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Chonnam National University Hwasun Hospital | Gwangju | 58128 | South Korea |
| Chosun University Hospital | Gwangju | 61453 | South Korea |
| Pusan National University Hospital | Pusan | 35015 | South Korea |
| Seoul National University Bundang Hospital (1) | Seongnam-si | 13620 | South Korea |
| Seoul National University Bundang Hospital (2) | Seongnam-si | 13620 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Kyung Hee University Hospital at Gangdong | Seoul | 05278 | South Korea |
| Gangnam Severance Hospital | Seoul | 06230 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | 07985 | South Korea |
| Korea University Guro Hospital | Seoul | 08308 | South Korea |
| The Catholic UNIV. of Korea Seoul St. Mary's Hospital | Seoul | 16591 | South Korea |
| The Catholic UNIV. of Korea Uijeongbu St. Mary's Hospital | Uijeongbu-si | 11765 | South Korea |
Study to Assess the Efficacy and Safety of Treatment of Articular Cartilage Lesions With CartiLife® |
| NCT03517046 | Clinical Study Report | View IPD | Study to Assess the Safety of Treatment of Articular Cartilage Lesions With CartiLife® |