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 groupSponsors and collaborators
Source ClinicalTrials.gov