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

Phase 1

• Conditions: Ischemic heart disease

• Registration Number: JPRN-UMIN000018709
• Lead Sponsor: Kyoto University Graduate School of Medicine Department of Cardiovascular Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the adverse effect and side effect within 24 weeks after the treatment

Secondary Outcome Measures

Name	Time	Method
To assess cardiac function and coronary perfusion within 24 weeks after the treatment using New York Heart Association (NYHA) functional class, Canadian Cardiovascular Society (CCS) class, coronary angiography, myocardial scintigraphy, echocardiography, and cardiac magnetic resonance imaging (MRI)