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 sites5 target enrollmentSeptember 1, 2015

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Ischemic heart disease
Sponsor: Kyoto University Graduate School of Medicine Department of Cardiovascular Surgery
Enrollment: 5
Status: Not yet recruiting
Last Updated: 2 years ago

No summary available.

Registry

who.int

Start Date

September 1, 2015

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Kyoto University Graduate School of Medicine Department of Cardiovascular Surgery

•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.