UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009066 |
|---|---|
| Receipt number | R000010643 |
| Scientific Title | Clinical trial of autologous adiose tissue derived stromal cell therapy for ischemic heart failure |
| Date of disclosure of the study information | 2012/10/09 |
| Last modified on | 2020/10/15 12:07:54 |
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Basic information
Public title
Clinical trial of autologous adiose tissue derived stromal cell therapy for ischemic heart failure
Acronym
Heart regeneration therapy by autologous Adipose Tissue Derived Stromal Cells
Scientific Title
Clinical trial of autologous adiose tissue derived stromal cell therapy for ischemic heart failure
Scientific Title:Acronym
Heart regeneration therapy by autologous Adipose Tissue Derived Stromal Cells
Region
| Japan |
Condition
Condition
Ischemic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of intracoronary administration of autologus adipose tissue derived stromal cells to ischemic heart failure patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assesment of safety in the context of adverse events defined in the implementation protocol.
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
Intracoronary administration of autologus adipose tissue derived regenerative cells.(3.33X10^5cell/Kg or 6.6X10^5cell/Kg)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Heart failure patients occured by prior ischemic event whose ejection fraction must be less than 40%.
Key exclusion criteria
*Complicated severe other organ disease.
*Patient with malignancy.
*History of chemotherapy or irradiation within 4 weeks.
*Patient with immunodeficiency
*Pregnancy or possibility of pregnancy
*Candidate who are judged to be not applicable to this study by doctors.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | SHUICHI |
| Middle name | |
| Last name | KANEKO |
Organization
Kanazawa University
Division name
Disease Control and Homeostasis
Zip code
920-8641
Address
13-1, Takaramachi, Kanazawa-shi, Ishikawa-pref
TEL
076-265-2000
mtakamura@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Takamura |
Organization
Kanazawa University Hospital
Division name
Department of Cardiology
Zip code
9208641
Address
13-1, Takaramachi, Kanazawa-shi, Ishikawa-pref
TEL
076-265-2238
Homepage URL
mtakamura@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Department of Cardiovascular Medicine, Graduate school of Medical Science, Kanazawa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical committee
Address
13-1, Takaramachi, Kanazawa
Tel
076-265-2103
rinri@med.kanazawa-u.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
金沢大学付属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 09 | 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
4
Results
Performed 4 cases.
Safety and clinical benefit were confirmed.
Results date posted
| 2020 | Year | 10 | Month | 15 | Day |
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
| 2012 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 09 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 09 | Day |
Last modified on
| 2020 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010643
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
