UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000660 |
|---|---|
| Receipt number | R000000797 |
| Scientific Title | Development of new strategy for end stage dilated cardiomyopathy, a combination of left ventricular assist device and aoutologous myoblast sheets |
| Date of disclosure of the study information | 2007/04/01 |
| Last modified on | 2021/01/27 09:47:48 |
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Basic information
Public title
Development of new strategy for end stage dilated cardiomyopathy, a combination of left ventricular assist device and aoutologous myoblast sheets
Acronym
A combination of left ventricular assist device and aoutologous myoblast sheets for end stage dilated cardiomyopathy
Scientific Title
Development of new strategy for end stage dilated cardiomyopathy, a combination of left ventricular assist device and aoutologous myoblast sheets
Scientific Title:Acronym
A combination of left ventricular assist device and aoutologous myoblast sheets for end stage dilated cardiomyopathy
Region
| Japan |
Condition
Condition
End stage dilated cardiomyopathy patients who need LVAS
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 in the combination with left ventricular assist system (LVAS) against end stage 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 in the combination with LVAS implantation.
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
End stage dilated cardiomyopathy
Requiring LVAS
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
6
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 city, Osaka
TEL
06-6879-3154
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Goro Matsumiya |
Organization
Osaka University Graduate school of medicine
Division name
Cardiovascular surgery
Zip code
Address
2-2 Yamadaoka Suita city, Osaka
TEL
06-6879-3154
Homepage URL
matsumg@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
none
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 04 | 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
| 2006 | Year | 09 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 03 | Month | 29 | Day |
Last modified on
| 2021 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000797
