Clinical trial on the safety of myocardium regenerative therapy for ischemic heart disease using biodegradable polymeric carrier and basic fibroblast growth factor - Clinical trial on the safety of myocardium regenerative therapy for ischemic heart disease using biodegradable polymeric carrier and basic fibroblast growth factor

Kyoto University Graduate School of Medicine Department of Cardiovascular Surgery0 个研究点目标入组 5 人开始时间: 2015年9月1日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)Emergency case 2)Diabetes mellitus with poor control (HbA1c>10%) 3)Poor prognosis with life expectancy <1 year 4)Recent (within 3 months) medical history such as myocardial infarction, stroke, transient ischemic attach, and severe allergic reactions. Alcoholic abuse requiring medical treatment within 1 year 5)Diabetic retinopathy which is being treated. Of note, may be enrolled if ophthalmologist decide that the retinopathy can be cured by the time of application of bFGF. 6)Dependent on chronic hemodyalisis 7)Patients participating clinical study using bFGF or gene therapy in the past 8)Patients who have known history of malignancy within 5 years, of note, carcinoma in-situ is not included. 9)Pregnant or expecting pregnancy women. Men who wish his partner to be pregnant. 10)Patients who have hemodynamic instability before the application of bFGF gelatin hydrogel sheet, or who are thought to be high-risk for the treatment. 11)Patients in whom it is not safe or appropriate to conduct the study judged by the principal investigator or other investigators.

发起方

Kyoto University Graduate School of Medicine Department of Cardiovascular Surgery