UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010453 |
|---|---|
| Receipt number | R000012219 |
| Scientific Title | Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS) |
| Date of disclosure of the study information | 2013/04/10 |
| Last modified on | 2017/01/04 12:12:18 |
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Basic information
Public title
Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)
Acronym
Cardiac Progenitor Cell Transfer for Univentricular Heart
Scientific Title
Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)
Scientific Title:Acronym
Cardiac Progenitor Cell Transfer for Univentricular Heart
Region
| Japan |
Condition
Condition
Hypoplastic left heart syndrome
Single right ventricle
Single left ventricle
Classification by specialty
| Cardiology | Vascular surgery | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac progenitor cells in patients with univentricular heart disease. Patients with preoperative high-risk group or whose cardiac function did not recover postoperatively eventually have no choice other than heart transplantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The primary outcome measure is to evaluate the cardiac function improvement by echocardiography, ventriculography, and cardiac MRI, which are conducted before and 3 months after surgical treatment.
Key secondary outcomes
The secondary outcome measure is to determine the cardiac function improvements by three different imaging modalities at 12 months after treatment. Clinical symptoms and BNP levels will be assessed at 3- and 12-months after treatment and compared with control group.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
(Stage 1) single dose, intracoronary infusion of 0.3 million cell/kg cardiac progenitor cells (cell infusion group).
Interventions/Control_2
(Stage 2) Rescuing transplantation is applicable in patients, along with their written consent, 4 months after palliations who were assigned as control group in stage 1.
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
| Not applicable |
Age-upper limit
| 20 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Age: Age is 0 year or more and 20 years or less at the time of patient enrollment.
2) The patients have functional single ventricular physiology with the indication to have stage-2 or -3 palliative surgeries.
3) The ventricular ejection fraction <60%.
Key exclusion criteria
1) Cardiogenic shock
2) A patient with unstoppable extracorporeal circulation
3) A patient with lethal, uncontrollable arrhythmia
4) A patient with a complication of coronary artery disease
5) A patient with a complication of brain dysfunction due to circulatory failure
6) A patient with malignant neoplasm
7) A patient with a complication of serious neurologic disorder
8) A patient with high-grade pulmonary embolism or pulmonary hypertension
9) A patient with high-grade renal failure
10) A patient with multiple organ failure
11) Active infection (including endocarditis)
12) Sepsis
13) Active hemorrhagic disease (e. g. gastrointestinal bleeding, injury)
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemasa Oh |
Organization
Okayama University Hospital
Division name
Center for Innovative Clinical Medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
+81-086-235-6506
hidemasa@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidemasa Oh |
Organization
Okayama University Hospital
Division name
Center for Innovative Clinical Medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
+81-086-235-6506
Homepage URL
http://shin-iryo.jp/section/index.html
hidemasa@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Translational Research Informatics Center
Name of secondary funder(s)
Ministry of Health, labour and Welfare
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
岡山大学病院(岡山市）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 09 | Day |
Last modified on
| 2017 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012219
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