UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000009066
Receipt No. 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 (Ver. 13)

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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
Email 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
Email mtakamura@m-kanazawa.jp

Sponsor
Institute Kanazawa University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010643