Phase 2 CartiLife® for Knee Cartilage Defects
This study is testing a treatment called CartiLife® for adults with knee cartilage damage due to injury or wear-and-tear. CartiLife® uses your own cartilage cells, grown into small beads, which are then implanted into the damaged area of your knee. Researchers want to see if CartiLife® can help regenerate (regrow) cartilage and improve how your knee functions, including sports and recreational activities. They will measure this improvement 48 weeks after the procedure. You might be able to join if you are over 18 and have a specific size of cartilage lesion in your knee. The study is currently unclear on its recruitment status and plans to enroll 25 participants.
- Study design
- This is an open-label, Phase 2 study, meaning both you and your doctors will know you are receiving CartiLife®. It plans to enroll 25 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your knee function and cartilage defect volume will be measured 48 weeks after the operation.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 2 Clinical Trial of CartiLife® in the United States
At a glance
Conditions
NCT04744402
Where you'd take part
This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Biosolutions Clinical Research Center
La Mesa, Californiastudy coordinator listed
Recruiting
Horizon Clinical Research
La Mesa, Californiastudy coordinator listed
Recruiting
Lafayette General Health
Lafayette, Louisianastudy coordinator listed
Recruiting
Ohio State University
Columbus, Ohiostudy coordinator listed
Recruiting
Tilda Research
Irvine, Californiastudy coordinator listed
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jungsun Lee, Ph.D · STUDY_DIRECTOR · Biosolution Co., Ltd.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Exclusion
What this trial measures
- Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) function (sports and recreational activities)Week 0 (pre-operation) to Week 48 (post-operation)
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.
- Change in volume fill of cartilage defect scoreWeek 0 (pre-operation) to Week 48 (post-operation)
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).