The clinical study for the joint treatment by nextgeneration allogeneic chondrocyte sheets (NACS)

JRCT ID: jRCTa030240663

Registered date:05/02/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cartilage defects associated with osteoarthritis of the knee
• Date of first enrollment: 05/02/2025
• Target sample size: 4
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

High tibial osteotomy
Allogeneic cell sheet implantation on cartilage defects

Outcome(s)

Primary Outcome

Primary outcome Measure of safety:
frequency and content of adverse events

Secondary Outcome

Secondary outcome Measure of safety:
Types of non-severe adverse events and frequency

Secondary outcome Measure of efficacy:
1.Evaluation of the patient self-assessed outcome scores by J-KOOS and clinical evalution by Lysholm Knee
Score
2.X-ray
3.MRI
4.arthroscopic evaluation
5.pathological evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 60age old
• Gender: Both

Include criteria

Patients must meet all of the following criteria and have the ability to give informed consent
1. 20 to 60 years of age, either male or female
2. Have a cartilage defect of the knee joint
3. Written consent must be obtained from the patient regarding participation in the clinical research
4. Cartilage defect under arthroscopy of greater than or equal to Outerbridge classification Grade III
5. The patellofemoral joint and condyle of the femur must have a cartilage defect or defects which can be fully coverd by allogeneic chondrocyte sheets and which have traditionally been treated by marrow simulation
techniques or osteohondral autografts

Exclude criteria

Patients who meet any of the following exclusion criteria will not be included.
1. Patients for whom it is difficult to obtain informed consent
2. Patients with complications that may interfere with general anesthesia surgery or that may affect knee
surgery
3. Those with problematic infectious diseases (including positive for HBV, HCV, HIV, HTLV-1, syphilis, etc.)
4. Those with a history of surgical treatment for cartilage lesions
5. Women who are pregnant or may be pregnant, or women who are breastfeeding
6. Other cases that the clinical research director or research co-investigator judges to be causing serious
hindrance to the treatment in this clinical study or that may cause serious hindrance to the treatment.

Related Information

• Primary Sponsor: Sato Masato