Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy

Phase I Study to Evaluate the Efficacy and Safety of Intramyocardial Implantation of Peripheral Mononuclear Cells With CD34+ Stem Cells in Patient With Ischemic Cardiomyopathy After Preparatory Course of Shock - Wave Therapy

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01615250

Acronym

ISCIC

Enrollment

Registered

2012-06-08

Start date

2012-01-31

Completion date

2016-01-31

Last updated

2012-06-11

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

Conditions

Heart Failure

Brief summary

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.

Interventions

BIOLOGICALIntramyocardial implantation of stem cells

Intramyocardial implantation of autologous peripheral mononuclear cells with CD34+ stem cells by NOGA.XP navigation system. Сell concentration is 200 million cells in 1 ml.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Change in global left ventricular ejection fraction and regional wall motion score index	6 and12 months	Change in global left ventricular ejection fraction and regional wall motion score index.

Secondary

Measure	Time frame	Description
Incidence of the major adverse cardiac events	6 and 12 months	Incidence of the major adverse cardiac events.

Countries

Ukraine

Contacts

Primary ContactIurii I Karpenko, Dr, PhD

arcard2@gmail.com+38048750113

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026