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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008013
Receipt No. R000009426
Scientific Title Safety and Efficacy of Autologous Myoblast Sheets Treatment for Patients with Severe Heart Failure due to Chronic ischemic Heart Disease.
Date of disclosure of the study information 2012/05/23
Last modified on 2014/11/24

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Basic information
Public title Safety and Efficacy of Autologous Myoblast Sheets Treatment for Patients with Severe Heart Failure due to Chronic ischemic Heart Disease.
Acronym Safety and Efficacy of Autologous Myoblast Sheets Treatment for Patients with Severe Heart Failure due to Chronic ischemic Heart Disease.
Scientific Title Safety and Efficacy of Autologous Myoblast Sheets Treatment for Patients with Severe Heart Failure due to Chronic ischemic Heart Disease.
Scientific Title:Acronym Safety and Efficacy of Autologous Myoblast Sheets Treatment for Patients with Severe Heart Failure due to Chronic ischemic Heart Disease.
Region
Japan

Condition
Condition Severe heart failure due to chronic ischemic heart disease
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This multicenter study validates the primary outcome measure, investigates the safety and efficacy, and investigates feasibility of delivery method of the investigational product.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in LVEF at 26 weeks after the transplantation.
Key secondary outcomes

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
Interventions/Control_1 Autologous skeletal myoblast sheet
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients who are chronic ischemic heart disease.
(2) Patients who are classified as NYHA class 3 or 4.
(3) Patients who are heart failure even under maximal oral medication including digitalis, diuretic, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, aldosterone antagonist and oral inotropic agents.
(4) Patients of 20 years or more at the time of obtaining informed consent.
(5) Patients who are concerned with worsening heart failure even though standard treatments such as CABG, mitral valvuloplasty, surgical ventricular restoration, CRT, and PCI were conducted over 3 months ago .
(6) Patients who have less than LVEF 35 percent determined by echocardiography at rest.
(7) Patients who provide first-person informed consent.
(8) Patients who are expected to be resident in Japan about two years after obtaining informed consent.
Key exclusion criteria (1) Patients who have signs of skeletal muscle disease.
(2) Patients under treatment with thyroid hormone.
(3) Patients with infectious disease(HIV,HBV,HCV,HTLV1).
(4) Patients in shock due to worsening heart failure.
(5) Patients with intercurrent cardiovascular abnormalities that are judged to affect the clinical trial by the investigator or the sub investigators.
(6) Patients with irreversible organ failure other than the heart.
(7) Patients with a malignant tumor.
(8) Patients who are pregnant or possibly pregnant.
(9) Patients who cannot receive a blood transfusion.
(10) Patients with a history of drug addiction or alcohol addiction within 6 months before obtaining informed consent.(11) Patients with hypersensitivity to antibiotics or animal origin materials such as fetal bovine serum.
(12) Patients with severe pulmonary hypertension.
(13) Patients with a history of other clinical study within 6 months.
(14) Patients who are judged to be inappropriate for the study by the investigator or the sub investigators.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Sawa
Organization Osaka University Hospital
Division name Cardiovascular surgery
Zip code
Address 2-15 Yamadaoka, Suita-shi, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Terumo Corporation
Division name Clinical Development Department
Zip code
Address
TEL 0465-81-4104
Homepage URL
Email kazuo_tamada@terumo.co.jp

Sponsor
Institute Terumo Corporation
Institute
Department

Funding Source
Organization Terumo Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2012 Year 05 Month 23 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 Completed
Date of protocol fixation
2012 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 05 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
2012 Year 05 Month 22 Day
Last modified on
2014 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009426

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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