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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
104
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
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
Inje University Haeundae Paik Hospital
Busan, South Korea
Kosin University Gospel Hospital
Busan, South Korea
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).
Time frame: 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.
Time frame: From Week 0 to Week 48, post-operation
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.
Time frame: 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.
Time frame: At Week 0 to Week 8, 24, 48 and 96, post-operation
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Chungnam National University Hospital
Daejeon, South Korea
Chonnam National University Hwasun Hospital
Gwangju, South Korea
Chosun University Hospital
Gwangju, South Korea
Pusan National University Hospital
Pusan, South Korea
Seoul National University Bundang Hospital (1)
Seongnam-si, South Korea
Seoul National University Bundang Hospital (2)
Seongnam-si, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
...and 8 more locations
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).
Time frame: 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.
Time frame: 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.
Time frame: 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'.
Time frame: 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.
Time frame: 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.
Time frame: At Week 0 (pre-operation), and up to 24 Months (post-operation)