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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004823
Receipt No. 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

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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
Email

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
Email hidemasa@md.okayama-u.ac.jp

Sponsor
Institute Center for Innovative Clinical Medicine, Okayama University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005732

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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