Status:
COMPLETED
Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)
Lead Sponsor:
Okayama University
Collaborating Sponsors:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Conditions:
Hypoplastic Left Heart Syndrome
Single Right Ventricle
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
Following the safety verification of the Phase I study (TICAP trial) that has been implemented and completed, the efficacy will be verified in this Phase II clinical study. The rationale of this study...
Eligibility Criteria
Inclusion
- Age: Age is 0 year or more and 20 years or less at the time of enrollment.
- The patients have functional single ventricular physiology with the indication to have stage-2 or -3 palliative surgeries.
- The ventricular ejection fraction \<60%.
Exclusion
- Cardiogenic shock
- A patient with unstoppable extracorporeal circulation
- A patient with lethal, uncontrollable arrhythmia
- A patient with a complication of coronary artery disease
- A patient with a complication of brain dysfunction due to circulatory failure
- A patient with malignant neoplasm
- A patient with a complication of serious neurologic disorder
- A patient with high-grade pulmonary embolism or pulmonary hypertension
- A patient with high-grade renal failure
- A patient with multiple organ failure
- Active infection (including endocarditis)
- Sepsis
- Active hemorrhagic disease (e. g. gastrointestinal bleeding, injury)
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01829750
Start Date
April 1 2013
End Date
September 1 2016
Last Update
December 7 2021
Active Locations (1)
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1
Okayama University
Okayama, Japan, 700-8558