UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015893 |
|---|---|
| Receipt number | R000016520 |
| Scientific Title | exploratory study for children severe cardiomyopathy using YS0001 |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2019/05/07 10:49:16 |
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Basic information
Public title
exploratory study for children severe cardiomyopathy using YS0001
Acronym
exploratory study for children severe cardiomyopathy using YS0001
Scientific Title
exploratory study for children severe cardiomyopathy using YS0001
Scientific Title:Acronym
exploratory study for children severe cardiomyopathy using YS0001
Region
| Japan |
Condition
Condition
Severe Cardiomyopathy in Pediatric patietns
Classification by specialty
| Cardiology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy study of autologous myoblast sheet for children
Severe cardiomyopasthy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary endopoint is to assess the safty
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
Culture of autologous skeletal myoblasts and engineering myoblast sheets. Transplantation of myoblast sheets to 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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Severe myopathy
NYHA Class iii
Ejection fraction =<35%]
Key exclusion criteria
Cardiomyopathy without other surgical options persisitent NYHA Class =>iii HF symptoms refractory to maximal medical therapy Ejection fraction =<35%
Target sample size
3
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 Osaka Japan
TEL
06-6879-3154
sawa@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Taira |
Organization
Osaka University hospital
Division name
Cardiovascular Surgery
Zip code
Address
2-15 Yamadaoka Suita Osaka Japan
TEL
06-6879-3154
Homepage URL
taira@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Surgery, Graduate School of medicine, Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for medical research and development
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 05 | 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
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 10 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016520
