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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018709
Receipt No. 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

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Basic information
Public title Clinical trial on the safety of myocardium regenerative therapy for ischemic heart disease using biodegradable polymeric carrier and basic fibroblast growth factor
Acronym Clinical trial on the safety of myocardium regenerative therapy for ischemic heart disease using biodegradable polymeric carrier and basic fibroblast growth factor
Scientific Title Clinical trial on the safety of myocardium regenerative therapy for ischemic heart disease using biodegradable polymeric carrier and basic fibroblast growth factor
Scientific Title:Acronym 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
1st name
Middle name
Last name Kenji Minakata
Organization Kyoto University Graduate School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
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
1st name
Middle name
Last name Ayaka Toya Yoko Tsukiyama
Organization Kyoto University Graduate School of Medicine
Division name Department of Cardiovascular Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2015 Year 07 Month 14 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021508

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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