Phase 2 Clinical Trial of CartiLife® in the United States
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBiosolution Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Autologous Chondrocyte Implantation (CartiLife®)
DrugCartiLife 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
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: CartiLife®Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 0 (pre-operation) to Week 48 (post-operation)2
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).
Time frame
Week 0 (pre-operation) to Week 48 (post-operation)Secondary outcomes
1
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.
Time frame
Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)2
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.
Time frame
Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)3
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.
Time frame
Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)4
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.
Time frame
Week 0 (pre-operation) to Week 8, 24 and 48 (post-operation)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov