Phase I exploratory clinical research on the use of High-Density Mesenchymal Stem Cell Scaffold-Free Autologous Constructs derived from adipose tissue for the donor site of mosaic plasty plugs for osteochondral regeneration therapy

Phase 1

• Conditions: Patients with cartilage injury, osteochondritis dissecans, disengaged osteochondral bone fracture, or idiopathic osteonecrosis of the knee joint

• Registration Number: JPRN-UMIN000017944
• Lead Sponsor: Kyushu University Hospital Department of Orthopedic Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-01
• Study Completion: 2020-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Subjects that meet the following criteria will be excluded from the trial. 1) Has past undergone osteochondral surgery 2) Has past suppurative arthritis in the affected area 3) Has past rheumatism, gout or other arthritis 4) Has present or past contagious disease within 3 months of registering for the trial 5) Positive for syphilis , HBs antigens, HCV, HIV parvovirus or HTLV antigens in the screening test results 6) Was drawn 200ml of whole blood within one month (or 200ml of blood components was drawn within two weeks) of registering 7) Is currently taking antithrombotic or anticoagulant drugs 8) APTT over 41 seconds and PT over 13.5 seconds in the screening test results 9) Is currently undergoing treatment for a malignant tumor or underwent treatment for a malignant tumor (excluding intraepithelial neoplasia) within the last 5 years 10) Has any congenital metabolism or bone disorders 11) Has past history of drug or alcohol abuse 12) Is taking steroids like prednisolone systemically 5mg/day or is taking any immune suppressant drugs 13) Participate other clinical research within 3 months before registration 14) Has a history of drug hypersensitivity reactions (antibacterial agents using cultivated cells such as penicillin etc) 15) Has hypersensitivity for animals (especially for bovine) 16) Has a history of anaphylaxis 17) Pregnant, capable of pregnancy and lactating women 18) Unsuitable for this trial judged by PI or SI

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence rate of the adverse events and side effects that occur after grafting

Secondary Outcome Measures

Name	Time	Method
Evaluation of osteochondral regeneration in the HDMAC plug implanted area compared with the non implanted area by MRI and arthroscopy with ICRS scoring