UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018709
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

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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 or person

Institute

Kyoto University Graduate School of Medicine Department of Cardiovascular Surgery

Institute

Department

Personal name



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

Value
https://center6.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