Unique ID issued by UMIN | UMIN000018709 |
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Receipt number | R000021508 |
Scientific Title | Clinical trial on the safety of myocardium regenerative therapy for ischemic heart disease using biodegradable polymeric carrier and basic fibroblast growth factor |
Date of disclosure of the study information | 2015/09/01 |
Last modified on | 2016/08/18 13:04:24 |
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
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
Japan |
Ischemic heart disease
Cardiology | Cardiovascular surgery |
Others
NO
To assess the safety and efficacy of administration of gelatin hydrogel sheet incorporating with basic fibroblast growth factor (bFGF) to patients with ischemic heart disease
Safety,Efficacy
Exploratory
Pragmatic
Phase I,II
To assess the adverse effect and side effect within 24 weeks after the treatment
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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Maneuver |
A single application of gelatin hydrogel sheet incorporating with 200 ug of basic fibroblast growth factor (bFGF)
To assess the adverse effect within 24 weeks after the treatment
20 | years-old | <= |
80 | years-old | > |
Male and Female
1) Candidates for coronary artery bypass grafting, with or without concomitant procedures, under the diagnosis of ischemic heart disease
2) Patients who have ischemic and viable myocardium, proved by echocardiography, MRI, and cardiac scintigraphy (99mTc-Tetrofosmin-single photon emission computed tomography : 99mTc-TF SPECT)
3) Patients who have myocardium which is not suitable to be bypassed at least one of the three major coronary territories
4) Age between 20 and 80 years old at the enrollment
5) Informed consent is obtained
6) Patients who are judged suitable for the study by the principal investigator and other investigators
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.
5
1st name | |
Middle name | |
Last name | Kenji Minakata |
Kyoto University Graduate School of Medicine
Department of Cardiovascular Surgery
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
075-751-3780
minakata@kuhp.kyoto-u.ac.jp
1st name | |
Middle name | |
Last name | Ayaka Toya Yoko Tsukiyama |
Kyoto University Graduate School of Medicine
Department of Cardiovascular Surgery
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
075-751-3780
cvs@kuhp.kyoto-u.ac.jp
Kyoto University Graduate School of Medicine Department of Cardiovascular Surgery
Ministry of Health, Labour and Welfare
Japanese Governmental office
NO
2015 | Year | 09 | Month | 01 | Day |
Unpublished
Preinitiation
2015 | Year | 07 | Month | 14 | Day |
2015 | Year | 09 | Month | 01 | Day |
2015 | Year | 08 | Month | 18 | Day |
2016 | Year | 08 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021508
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