UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004823 |
|---|---|
| Receipt number | R000005732 |
| Scientific Title | Transcoronary Infusion of Cardiac Progenitor Cells in Patients with Single Ventricle Physiology (TICAP) |
| Date of disclosure of the study information | 2011/01/05 |
| Last modified on | 2013/01/08 09:49:12 |
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Basic information
Public title
Transcoronary Infusion of Cardiac Progenitor Cells in Patients with Single Ventricle Physiology (TICAP)
Acronym
Cell Therapy in Patients with Single Ventricle Physiology
Scientific Title
Transcoronary Infusion of Cardiac Progenitor Cells in Patients with Single Ventricle Physiology (TICAP)
Scientific Title:Acronym
Cell Therapy in Patients with Single Ventricle Physiology
Region
| Japan |
Condition
Condition
Children with hypoplastic left heart syndrome or related single ventricle physiology
Classification by specialty
| Cardiology | Pediatrics | Cardiovascular surgery |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to test the safety and feasibility of intracoronary infusion of autologous cardiac progenitor cells in children with single ventricle physiology.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Monitoring major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.
Key secondary outcomes
Monitoring the rate of composite serious adverse events with death excluded and the rate of other complication.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The study patients will be involving 7 treated and 7 control subjects. Autologous cardiac progenitor cells are isolated from patients' own cardiac tissues obtained during palliative shunt procedure. Patients will receive 0.3 million/kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.
Interventions/Control_2
staged shunt procedures include Norwood-Glenn, Glenn or Fonatan operation
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
| 0 | years-old | <= |
Age-upper limit
| 6 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Infants with single ventricle physiology undergoing second to third palliative shunt surgeries will be recruited into the study. Patients between 0 and 6 years of age are eligible if written informed consent can be obtained.
Key exclusion criteria
Exclusion criteia are the presence of cardiogenic shock, Eisenmenger syndrome, uncontrollable arrhythmia, severe chronic diseases, infections, cancer, or unwillingness to participate.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidemasa Oh |
Organization
Okayama University Hospital
Division name
Department of Regenerative Medicine, Center for Innovative Clinical Medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-6506
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rie Yokoyama |
Organization
Okayama University Hospital
Division name
Department of Cardiovascular Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7357
Homepage URL
http://okayama-u-cvs.jp/siniryo.html
hidemasa@md.okayama-u.ac.jp
Sponsor or person
Institute
Center for Innovative Clinical Medicine, Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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（岡山県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 01 | Month | 05 | 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
| 2010 | Year | 12 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | 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
| 2011 | Year | 01 | Month | 05 | Day |
Last modified on
| 2013 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005732
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| Registered date | File name |
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| Registered date | File name |
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