Stem cells in Heart disease

Medical laser and stem cells in treatment ischemic heart disease

Status

Active, not recruiting

Phases

Phase 1Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-005371-40-PL

Enrollment

Registered

2014-07-02

Start date

2014-11-17

Completion date

Unknown

Last updated

2025-03-10

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

Conditions

Ischemic heart disease

Interventions

Product Name: Stem cells Pharmaceutical Form: Suspension for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - End stage CHNS - no possibility PCI or CABG - Optimal medical therapy - Symptoms (CCS III or IV) - viability front and / or side wall of the myocardium - EF> 30% Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: - Unstable ischemic heart disease, - Acute myocardial infarction, - Valvular heart disease, - Heart defect congenital or acquired, - EF <30%, - Severe arrhythmias, - Contraindications to general anesthesia, - Contraindications to cardiac surgery, - A disease in which life expectancy is less than 2 years, - Peripheral vascular disease, restrictive normal functioning., - allergic for high-osmolar contrast media, claustrophobia

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to demonstrate that the administration of stem cells taken from fat in observing the annual improve regional myocardial contractility in patients with end-stage ischemic heart disease disqualified from traditional treatments of myocardial revascularization.;Secondary Objective: Improvement in angina relief;Primary end point(s): Improvement of regional myocardial contractility - changes in fractional shortening of the treated area assessed cardiac MRI;Timepoint(s) of evaluation of this end point: 1 year	—

Measure

Time frame

Main Objective: The aim of the study is to demonstrate that the administration of stem cells taken from fat in observing the annual improve regional myocardial contractility in patients with end-stage ischemic heart disease disqualified from traditional treatments of myocardial revascularization.;Secondary Objective: Improvement in angina relief;Primary end point(s): Improvement of regional myocardial contractility - changes in fractional shortening of the treated area assessed cardiac MRI;Timepoint(s) of evaluation of this end point: 1 year

—

Secondary

Measure	Time frame
Secondary end point(s): Improved perfusion of the treated area through increased angiogenesis assessed on the basis of the quality of life, 6-minute walk test, echocardiography and reduce discomfort CCS class;Timepoint(s) of evaluation of this end point: 6 months, 1 year	—

Countries

Poland

Contacts

Public ContactBIURO WSPIERANIA BADAN I ROZWOJU

Szpital im. Jana Pawla II

a.piwowarczyk-bargiel@szpitaljp2.krakow.pl4812614 33 84

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026