Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)

Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS) - Cardiac Progenitor Cell Transfer for Univentricular Heart

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010453

Enrollment

Registered

2013-04-10

Start date

2013-04-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoplastic left heart syndrome Single right ventricle Single left ventricle

Interventions

(Stage 1) single dose, intracoronary infusion of 0.3 million cell/kg cardiac progenitor cells (cell infusion group). (Stage 2) Rescuing transplantation is applicable in patients, along with their writ

Eligibility

Sex/Gender

All

Inclusion criteria

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%.

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactHidemasa Oh

Okayama University Hospital Center for Innovative Clinical Medicine

hidemasa@md.okayama-u.ac.jp+81-086-235-6506

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026