The Post-marketing Surveillance to Evaluate the Efficacy of CHONDRON (Autologous Cultured Chondro… (NCT02539069) | Clinical Trial Compass
CompletedNot Applicable
The Post-marketing Surveillance to Evaluate the Efficacy of CHONDRON (Autologous Cultured Chondrocyte) by Arthroscopy
South Korea10 participantsStarted 2012-10-23
Plain-language summary
A clinical trial to evaluate the long-term efficacy and safety of Chondron (Autologous cultured Chondrocyte) administered through arthroscopy from the drug's 48 weeks efficacy and safety evaluation with 96 weeks follow-up in patients with knee cartilage defects.
Who can participate
Age range
15 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
. Patients with cartilage defects in their knee (Including Knee OA and Knee TA) \* For a single lesion, less than 15 cm2 cartilage defects; and for multiple lesions, less than 20 cm2
. Patients with misalignment of their tibia and femur, unstable ligament in their knee, or bony defects in the lesions of their knee, and/or who had been treated for alignment
. Patients which surrounding cartilage are normal
. Patients who were 15 years old or older
. Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form
Exclusion 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.
. Patients hypersensitive to gentamicin antibiotics
. Patients with inflammatory arthritis such as rheumatoid arthritis, gout arthritis
. Patients with arthritis related to autoimmune disease
. Pregnant, breast-feeding patients or those who have a possibility of pregnancy
. Patients with accompanying diseases other than articular cartilage defects, including tumors (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
. Patients who have a history of receiving radiotherapy, chemotherapy in the last 2 years (Exception: if the possibility of Chondron treatment is confirmed with doctor's clinical decision).
. Patients with diabetes (however, patients whose blood sugar test results are normal and do not have any complication of diabetes, when a written opinion that CHONDRON administration is possible is appended by a doctor are excluded)