RecruitingPhase 2

Phase 2 Clinical Trial of CartiLife® in the United States

United States25 participantsStarted 2020-10-28

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. Subject who can move independently and has a mechanically stable knee (normal ligament status)
. Subject with intact or partial meniscus status (\>50% of meniscus)
. Subject who has KOOS pain value less than 60 at baseline
. Subject who agrees to actively participate in a rehabilitation protocol and follow-up program

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in KOOS (Knee Injury and Osteoarthritis Outcome Score) function (sports and recreational activities)

Timeframe: Week 0 (pre-operation) to Week 48 (post-operation)

Change in volume fill of cartilage defect score

Timeframe: Week 0 (pre-operation) to Week 48 (post-operation)

Trial details

NCT IDNCT04744402

SponsorBiosolution Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

TaeKyung Kim, MA

+82234468884 taekyung1215@biosolutions.co.kr

View on ClinicalTrials.gov More Articular Cartilage Defect trials