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 - Clinical research on osteochondral tissue regeneration using adipose derived mesenchymal stem cell constructs

Kyushu University Hospital Department of Orthopedic Surgery0 个研究点目标入组 5 人开始时间: 2015年7月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

发起方

Kyushu University Hospital Department of Orthopedic Surgery