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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003273
Receipt No. R000003959
Scientific Title Development of new strategy for severe heart failure using aoutologous myoblast sheets.
Date of disclosure of the study information 2010/03/01
Last modified on 2018/09/18

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Basic information
Public title Development of new strategy for severe heart failure using aoutologous myoblast sheets.
Acronym Autologus myoblast sheets transplantation therapy for ischaemic and dilated cardiomyopathy.
Scientific Title Development of new strategy for severe heart failure using aoutologous myoblast sheets.
Scientific Title:Acronym Autologus myoblast sheets transplantation therapy for ischaemic and dilated cardiomyopathy.
Region
Japan

Condition
Condition ischaemic cardiomyopathy, dilated cardiomyopathy
Classification by specialty
Cardiovascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Development of establishment of the methods utilizing aoutologous myoblast sheets cultured from skeletal muscle against ischaemic or dilated cardiomyopathy. The safety and the efficacy are tested.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Adverse events
Key secondary outcomes Caridac function

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 Device,equipment Behavior,custom
Maneuver
Interventions/Control_1 Culture of autologous skeltal myoblasts and engineering myoblast sheets. Transplantation of the myoblast sheets to the heart.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria ischaemic or dilated cardiomyopathy,
NYHA Class III and Class IV,
Ejection fraction <35%,
Key exclusion criteria Severe skeletal muscle disease,
Cancer,
Severe infection,
Alcoholic or drug addiction in recent six months,
Pregnancy,
Others (doctors dicision) ,
Target sample size 16

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

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Miyagawa
Organization Osaka University Graduate school of medicine
Division name Cardiovascular surgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3154
Homepage URL
Email miyagawa@surg1.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate school of medicine, Cardiovascular surgery
Institute
Department

Funding Source
Organization Research on Measures for Intractable Diseases
Organization
Division
Category of Funding 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 大阪大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 03 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 Completed
Date of protocol fixation
2009 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2010 Year 03 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
2010 Year 03 Month 01 Day
Last modified on
2018 Year 09 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003959

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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