Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)
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ClinicalTrials.gov Identifier: NCT01829750 |
Recruitment Status :
Completed
First Posted : April 11, 2013
Last Update Posted : January 5, 2017
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Condition or disease | Intervention/treatment | Phase |
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Hypoplastic Left Heart Syndrome Single Right Ventricle Single Left Ventricle | Genetic: Cardiac progenitor cell infusion | Phase 2 |
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 is based on the animal studies that transplanted cardiac progenitor cells may regenerate damaged myocardium by giving rise to cardiac muscle and vascular cell types. Preclinical and phase I studies indicate the possibilities of cardiac function improvements and reduced myocardial fibrosis by progenitor cell infusion.
The efficacy of cell transplantation is assessed as the primary endpoint of the Phase II clinical study. The improvements of cardiac ejection fraction assessed by echocardiography, ventriculography, and cardiac MRI, which are conducted before and after treatment, are assessed as the evaluation items. The absolute values of the improvement of cardiac ejection fraction obtained by the above three imaging modalities before and after treatment are compared between two groups of the transplantation group and non-transplantation group.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 2 Study of Intracoronary Infusion of Cardiac Progenitor Cells in Patients With Univentricular Heart Disease |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | March 2016 |
Actual Study Completion Date : | September 2016 |

Arm | Intervention/treatment |
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Sham Comparator: Control
(Stage 1) No active intervention after standard surgical treatment (Stage 2) Rescuing transplantation by cardiac progenitor cell infusion is applicable in patients, along with their written consent, 4 months after palliations who were assigned as control group in stage 1. |
Genetic: Cardiac progenitor cell infusion
(Stage 1) Cardiac progenitor cell infusion in patients who assigned as active comparator group (Stage 2) Rescuing transplantation is applicable in patients, along with their written consent, 4 months after palliations who were allocated as control group in stage 1. |
Active Comparator: Cardiac progenitor cell infusion
(Stage 1) single dose, intracoronary infusion of 0.3 million cells/kg cardiac progenitor cells
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Genetic: Cardiac progenitor cell infusion
(Stage 1) Cardiac progenitor cell infusion in patients who assigned as active comparator group (Stage 2) Rescuing transplantation is applicable in patients, along with their written consent, 4 months after palliations who were allocated as control group in stage 1. |
- Cardiac function [ Time Frame: 3 Months ]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.
- Cardiac function [ Time Frame: 12 Months ]The secondary outcome measure is to determine the cardiac function improvements by three different imaging modalities at 12 months after treatment.
- Clinical symptoms [ Time Frame: 3 and 12 Months ]Clinical symptoms and BNP levels will be assessed at 3- and 12-months after treatment and compared with control group.

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Ages Eligible for Study: | up to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829750
Japan | |
Okayama University | |
Okayama, Japan, 700-8558 |
Principal Investigator: | Hidemasa Oh, M.D., Ph.D. | Okayama University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Hidemasa Oh, Professor, Okayama University |
ClinicalTrials.gov Identifier: | NCT01829750 |
Other Study ID Numbers: |
0329-18 MHLW25040101 ( Other Grant/Funding Number: MHLW25040101 ) |
First Posted: | April 11, 2013 Key Record Dates |
Last Update Posted: | January 5, 2017 |
Last Verified: | January 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Univentricular heart |
Heart Diseases Hypoplastic Left Heart Syndrome Cardiovascular Diseases |
Heart Defects, Congenital Cardiovascular Abnormalities Congenital Abnormalities |