UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029959 |
|---|---|
| Receipt number | R000034105 |
| Scientific Title | Japanese OMI treatment with Kit-positive cells for Enhanced Regeneration trial |
| Date of disclosure of the study information | 2017/11/14 |
| Last modified on | 2023/05/22 08:36:18 |
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Basic information
Public title
Japanese OMI treatment with Kit-positive cells for Enhanced Regeneration trial
Acronym
JOKER trial
Scientific Title
Japanese OMI treatment with Kit-positive cells for Enhanced Regeneration trial
Scientific Title:Acronym
JOKER trial
Region
| Japan |
Condition
Condition
Chronic ischemic heart failure
Classification by specialty
| Cardiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the safety and effectiveness of intracoronary infusion of autologous cardiac stem cells in patients with ischemic cardiomyopathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Frequency and severity of adverse events (death, ventricular arrhythmia, infection, bleeding, myocardial infarction, cardiac tumor, brain stroke, peripheral embolism, etc.) at 1, 3, 6, 9, 12, 15, 18, 21, 24 months after the cell infusion.
Key secondary outcomes
Symptom by NYHA classification, NT-proBNP, electrocardiogram, chest X-ray, cardiopulmonary exercise test, cardiac function by echocardiogram and magnetic resonance imaging, viability evaluation by myocardial scintigraphy.
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
| Other |
Interventions/Control_1
Autologous intracoronary single infusion of 1,000,000 cardiac stem cells via cardiac catheter.
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
Adult with ability to provide informed consent.
Left ventricular ejection fraction less than 40%.
Scheduled for elective surgical revascularization within 2 months.
Key exclusion criteria
Positive for HBs-Ag, HCV-Ab, HIV-Ab, or tests for syphilis.
Diabetic HbA1c greater than 8.5%.
Pregnant women.
Scheduled for additional interventions including ventriculoplasty.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Toru |
| Middle name | |
| Last name | Hosoda |
Organization
Sakakibara Heart Institute
Division name
Cardiology
Zip code
183-0003
Address
3-16-1 Asahi-cho, Fuchu-shi, Tokyo 183-0003, Japan
TEL
+81-42-314-3111
thosoda@shi.heart.or.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Hosoda |
Organization
Sakakibara Heart Institute
Division name
Cardiology
Zip code
183-0003
Address
3-16-1 Asahi-cho, Fuchu-shi, Tokyo 183-0003, Japan
TEL
+81-42-314-3111
Homepage URL
thosoda@shi.heart.or.jp
Sponsor or person
Institute
Sakakibara Heart Institute
Institute
Department
Personal name
Funding Source
Organization
Japan research promotion society for cardiovascular disease
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
CellBank of Japan Corp.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sakakibara Heart Institute IRB
Address
+81-42-314-3111
Tel
+81-42-314-3111
tiken@shi.heart.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
PB3170012
Org. issuing International ID_1
Kanto Shin-Etsu Welfare Office
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
公益財団法人 日本心臓血圧研究振興会附属 榊原記念病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 14 | 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
6
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Two participants were treated successfully with their own stem cells as initially planned. Due to the shortage of funding, however, the other four participants have not been treated yet.
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 14 | Day |
Last modified on
| 2023 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034105
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