UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047335 |
|---|---|
| Receipt number | R000053954 |
| Scientific Title | A prospective observational study of Induced Pluripoteint Stem Cell-derived Cardiac Spheres transplantation EXTENDed Follow-up |
| Date of disclosure of the study information | 2022/04/01 |
| Last modified on | 2024/04/01 10:03:58 |
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Basic information
Public title
A prospective observational study of Induced Pluripoteint Stem Cell-derived Cardiac Spheres transplantation EXTENDed Follow-up
Acronym
IPSCS-EXTEND study
Scientific Title
A prospective observational study of Induced Pluripoteint Stem Cell-derived Cardiac Spheres transplantation EXTENDed Follow-up
Scientific Title:Acronym
IPSCS-EXTEND study
Region
| Japan |
Condition
Condition
severe heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety of iPS cell-derived cardiomyocytes has not been established. The objective of the present study is to confirm the long-term safety (tumorogenicity, arrhythmia, etc.) and efficacy (improvement of left ventricular ejection fraction, left ventricular volume, etc.) after transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Long-term safety of iPS cell-derived cardiomyocyte transplantation
Key secondary outcomes
Long-term efficacy of iPS cell-derived cardiomyocyte transplantation
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects of the safety study of regenerative therapy with allogeneic induced pluripotent stem cell-derived cardiac spheres for severe heart failure (jRCTa032200189) approved by the Specified Certified Regenerative Medicine Committee.
Key exclusion criteria
Patients that do not meet the selection criteria.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Shimizu |
Organization
Keio University School of Medicine
Division name
Cardiovascular surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku
TEL
03-3353-1211
shimizu.md@gmail.com
Public contact
Name of contact person
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Kishino |
Organization
Keio University School of Medicine
Division name
Cardiology
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku
TEL
03-5843-6702
Homepage URL
ykishino@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
HeartSeed
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine, Independent Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku
Tel
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
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
| 2022 | 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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
https://jrct.niph.go.jp/latest-detail/jRCTa032200189
Management information
Registered date
| 2022 | Year | 03 | Month | 30 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053954
| 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 |
