UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013941 |
|---|---|
| Receipt number | R000016252 |
| Scientific Title | Novel Regenerative Therapy with Autologus Myoblast Sheet for Pediatric Heart Failure patients |
| Date of disclosure of the study information | 2014/05/13 |
| Last modified on | 2014/05/13 11:27:04 |
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Basic information
Public title
Novel Regenerative Therapy with Autologus Myoblast Sheet for Pediatric Heart Failure patients
Acronym
Novel Regenerative Therapy with Autologus Myoblast Sheet for Pediatric Heart Failure patients
Scientific Title
Novel Regenerative Therapy with Autologus Myoblast Sheet for Pediatric Heart Failure patients
Scientific Title:Acronym
Novel Regenerative Therapy with Autologus Myoblast Sheet for Pediatric Heart Failure patients
Region
| Japan |
Condition
Condition
Severe Cardiomyopathy in Pediatric patietns
Classification by specialty
| Cardiology | Pediatrics | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to evaluate the safty and feasibility of autologus myoblast sheet implantation for pediatric patients who suffer from severe heart failure which is refractory to standard therapy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Phase II
Assessment
Primary outcomes
Primary endopoint is to assess the safty, that is to evaluate adverse events during the study.
Key secondary outcomes
Secondary endpoints are to evaluate serial change of left ventricular function, to confirm successful procedures sheet implantation, and to evaluate QOL of patients.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Skeltal muscle is explanted from gastrocnemius of patient lower leg, and myoblasts are isolated. They are cultured at cell processing center and finaly are build up to myoblast sheets. They are implanted to surface of left ventricle through left thoractomy.
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
| 0 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)age of patient is under 18 years old
2)clinical diagnosis of severe cardiomyopathy
3)NYHA functional classification 3 or 4
4)Left ventricular Ejection Fraction is less than 35%
5)Written informed consent of patients themselvesor the parents
Key exclusion criteria
Patients who have the foillowings.
1)any degenerative muscle diseases.
2)active infection.
3)suffered from any malignant diseases within 5 years
4)infected by HIV, HBV, HCV or HTLV
5)functional single ventricle physiology
6)restrictive cardiomyopathy
7)irreversible hepatic or renal dysfuntion
8)severe mental retardation or chromosomal abnormality
9)severe pulmonary hyper tension
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Sawa |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Cardiovascular Surgery
Zip code
Address
2-2 Yamadaoka Suita Osaka Japan
TEL
+81-6-6879-3160
sawa@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Taira |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Cardiovascular Surgery
Zip code
Address
2-2 Yamadaoka Suita Osaka Japan
TEL
+81-6-6879-3154
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
Ministry of Health, Labour and Welfare Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
TERUMO
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（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 05 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 03 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 24 | 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 | 05 | Month | 13 | Day |
Last modified on
| 2014 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016252
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
