The clinical study for the joint treatment by allogeneic cell sheet

JRCT ID: jRCTa030190242

Registered date:05/03/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cartilage defects associated with osteoarthritis of the knee
• Date of first enrollment: 17/01/2017
• Target sample size: 10
• 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 efficacy:
1. Evaluation of the patient self-assessed outcome scores by J-KOOS and clinical evaluation by Lysholm Knee Score
2. X-ray
3. MRI
4. arthroscopic evaluation
5. photoacoustic evaluation
6. 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. Cartilage defect under arthroscopy of greater than or equal to Outerbridge classification Grade III
4. The patellofemoral joint and condyle of the femur must have a cartilage defect or defects which can be fully covered by allogeneic chondrocyte sheets and which have traditionally been treated by marrow stimulation techniques or osteochondral autografts

Exclude criteria

Patients who meet any one or more of the following criteria will be excluded
1. Obtaining informed consent from the patient is difficult
2. Having complications hindering surgery under general anesthesia or complications affecting knee surgery
3. Having problematic infectious disease (including testing positive for HBV, HCV, HIV, HTLV, FTA-ABS)
4. Having rheumatoid arthritis or other systemic inflammatory disease

Related Information

• Primary Sponsor: Masato Sato