UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012906 |
|---|---|
| Receipt number | R000015089 |
| Scientific Title | Development of treatment for severe heart failure using autologous myoblast sheet |
| Date of disclosure of the study information | 2014/01/21 |
| Last modified on | 2018/09/18 14:49:31 |
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Basic information
Public title
Development of treatment for severe heart failure using autologous myoblast sheet
Acronym
Autologous myoblast sheets transplantation therapy for cardiomyopathy
Scientific Title
Development of treatment for severe heart failure using autologous myoblast sheet
Scientific Title:Acronym
Autologous myoblast sheets transplantation therapy for cardiomyopathy
Region
| Japan |
Condition
Condition
Dilated cardiomyopathy, Ischemic cardiomyopathy
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety, feasibility, and efficacy study of autologous myoblast sheet for cardiomyopasthy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Improvement of LV ejection fraction
Key secondary outcomes
1) Feasibility of myoblast sheet implantation
2) Improvement of regional function
3) LV reverse remodeling
4) Improvement of symptoms and grade of heart failure
5) Adverse event
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Behavior,custom |
| Maneuver |
Interventions/Control_1
Culture of autologous skeletal myoblasts and engineering myoblast sheets. Transplantation of myoblast sheets to heart
Interventions/Control_2
Patients with maximal medical and surgical treatment
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) Dilated cardiomyopathy and ischemic cardiomyopathy
2) NYHA Class II,III, IV
3) Ejection fraction<35%
Key exclusion criteria
1) Severe skeletal muscle disease
2) Severe infection
3) Alcoholic or drug addiction in recent six months
4) Malignancy
5) Virus infection (HIV, HBV, HCV,HTLV)
6) Pregnancy
7) Others
Target sample size
40
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
06-6879-3154
sawa@surg1.med.osaka-u.ac.jp
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 Disease
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
大阪大学医学部付属病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 09 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 22 | 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
| 2014 | Year | 01 | Month | 21 | 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=R000015089
