UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003273 |
|---|---|
| Receipt number | 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 14:45:13 |
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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
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
miyagawa@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate school of medicine, Cardiovascular surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003959
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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