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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000003273 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | ischaemic cardiomyopathy, dilated cardiomyopathy | |
Classification by specialty |
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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 |
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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 | |||||
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Interventions/Control_5 | |||||
Interventions/Control_6 | |||||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | ischaemic or dilated cardiomyopathy,
NYHA Class III and Class IV, Ejection fraction <35%, |
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Key exclusion criteria | Severe skeletal muscle disease,
Cancer, Severe infection, Alcoholic or drug addiction in recent six months, Pregnancy, Others (doctors dicision) , |
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Target sample size | 16 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Osaka University Graduate school of medicine, Cardiovascular surgery |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003959 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |