The clinical study for the joint treatment by allogeneic cell sheet

Phase 2

• Conditions: Cartilage defects associated with osteoarthritis of the knee

• Registration Number: JPRN-jRCTa030190242
• Lead Sponsor: Masato Sato

Brief Summary

Ten participants were enrolled and received the combined surgeries of PD sheet transplantation and HTO. No serious adverse events were observed during the follow-up period up to 12 months after surgeries. KOOS and Lysholm Score at 12 months after surgeries were significantly improved respectively compared with those of preoperative status. These results indicated the safty and the efficacy of the treatment for the patients with osteoarthritis of the knee.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-05
• Study Completion: 2020-12-11
• Results First Posted: 2023-01-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome Measure of safety:<br>frequency and content of adverse events

Secondary Outcome Measures

Name	Time	Method
Secondary outcome Measure of efficacy:<br>1. Evaluation of the patient self-assessed outcome scores by J-KOOS and clinical evaluation by Lysholm Knee Score<br>2. X-ray<br>3. MRI<br>4. arthroscopic evaluation <br>5. photoacoustic evaluation<br>6. pathological evaluation