Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy (ISCIC)

Odessa National Medical University

Status and phase: Unknown; Phase 1

Conditions: Heart Failure

Treatments: Biological: Intramyocardial implantation of stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01615250

ISCIC-2012

Details and patient eligibility

About

This is a randomized study of efficiency and safety of intramyocardial implantation of peripheral mononuclear cells with high concentration of CD34+ stem cells in patients with myocardial ischemia after preparatory course of shock - wave therapy.

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ischemic cardiomyopaty and HF II-IV NYHA class
• MI more than 6 months before the study
• LVEF less than 35%
• Absence effect of coronary revascularization during 6 months
• Optimal pharmacological therapy no less than 8 weeks
• Heart transplantation is contraindicated
• Patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)
• Patients giving informed consent

Exclusion criteria

• Acute coronary syndrome
• Coronary revascularization less than 6 months
• Patients requiring surgical correction of post-MI aneurism
• LV wall thickness less than 5 mm in site of possible injection
• Patients with CRT implanted within 3 month before cells injection
• Clinically significant associated diseases
• Active oncology desiase
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Standard therapy

No Intervention group

Description:

Treatment with standard therapy. Cardiospec shock-wave therapy

Stem cells

Active Comparator group

Description:

Group of of intramyocardial implantation of peripheral mononuclear cells with CD34+ stem cells in patient with ischemic cardiomyopathy after preparatory course of shock - wave therapy.

Treatment:

Biological: Intramyocardial implantation of stem cells