UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial on the safety of myocardium regenerative therapy for ischemic heart disease using biodegradable polymeric carrier and basic fibroblast growth factor
Title of the study (Brief title)	Clinical trial on the safety of myocardium regenerative therapy for ischemic heart disease using biodegradable polymeric carrier and basic fibroblast growth factor
Region	Japan

Condition
Condition	Ischemic heart disease
Classification by specialty	Cardiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	To assess the adverse effect and side effect within 24 weeks after the treatment
Key secondary outcomes	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)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	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
Key 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.
Target sample size	5

Research contact person
Name of lead principal investigator	Kenji Minakata
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiovascular Surgery
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3780
Email	minakata@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Ayaka Toya Yoko Tsukiyama
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Cardiovascular Surgery
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL	075-751-3780
Homepage URL
Email	cvs@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine Department of Cardiovascular Surgery
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 09 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 07 Month 14 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 18 Day
Last modified on	2016 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021508