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
Qualifiers
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
Treatments tested in this trial
- Autologous Chondrocyte Implantation (CartiLife®)
Treatment groups
25 Participants
are divided into 1 treatment groupLocations
5Tilda Research92612, IrvineCalifornia, United States
Biosolutions Clinical Research Center91942, La MesaCalifornia, United States
Horizon Clinical Research91942, La MesaCalifornia, United States
Lafayette General Health70506, LafayetteLouisiana, United States
Sponsors and collaborators
Biosolution Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov