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Exploratory clinical trial on the efficacy and safety of allogeneic cultured chondrocyte kit for patients with focal cartilage defects due to osteoarthritis of the knee

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Knee osteoarthritis
Date of first enrollment	03/02/2025
Target sample size	60
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material Generic name: Human allograft tissue INN of investigational material: Human allograft tissue Therapeutic categoly code: - Dosage and Administration for investigational material: Prepare allogeneic cultured chondrocytes and biological tissue adhesive and transplant into the cartilage defect site Control material Generic name: Purified sodium hyaluronate INN of investigational material: Purified sodium hyaluronate Therapeutic categoly code: 3999 Dosage and Administration for investigational material: Usually, for adults, 1 syringe (25 mg of purified sodium hyaluronate per dose) is administered into the knee joint cavity 5 times in a row, once a week.

Outcome(s)

Primary Outcome	Efficacy safety Efficacy:Change in WOMAC Safety:The incidence of Adverse events and defect
Secondary Outcome	Efficacy safety Evaluation on Clinical Symptons:Evaluation by KOOS , IKDC score, VAS, SF-36 Evaluation on regenaration of cartilage tissue: arthroscopy, MRI, evaluation of the cartilage biopsy

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Patients diagnosed with osteoarthritis of the knee 2) Patients whose treatment area is between 2 cm2 and 18 cm2 on MRI and whose cartilage damage is focal 3) Patients who have undergone conservative treatment, including physical therapy, for three months prior to screening without success 4) Patients whose WOMAC total score is 20 or more and whose WOMAC Pain score is 5 or more at screening 5) Patients who are candidates for hyaluronic acid joint injections etc.
Exclude criteria	1) Patients in stage 4 of the Kellgren-Lawrence (KL) classification 2) Patients with varus or valgus deformity of the knee of 5 degrees or more compared to the normal value (FTA 175 degrees) 3) Patients with surgical treatment that requires treatment of the affected joint, or patients who have had surgical treatment of the knee joint within 3 months 4) Patients who have had osteotomy around the knee in the affected joint within 12 months 5) Patients with a BMI of 30 or more 6) Patients with cartilage defects in both knee joints 7) Patients with inflammatory arthritis associated with autoimmune diseases such as rheumatoid arthritis 8) Patients with inflammatory arthritis such as gout or pseudogout 9) Patients undergoing treatment for hyperuricemia 10) Patients with a history of hypersensitivity to bovine-derived proteins, porcine-derived proteins, and rice-derived proteins 11) Patients with a history of hypersensitivity to aminoglycoside antibiotics and polyene antibiotics 12) Patients who cannot use MRI etc.