Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy

Heart Failure Clinical Trial

— ISCIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01615250
• Other study ID #: ISCIC-2012
• Status: Recruiting
• Phase: Phase 1
• First received: June 6, 2012
• Last updated: June 8, 2012
• Start date: January 2012
• Est. completion date: January 2016

Study information

• Verified date: June 2012
• Source: Odessa National Medical University
• Contact: Iurii I Karpenko, Dr, PhD
• Phone: +38048750113
• Email: arcard2[@]gmail.com
• Is FDA regulated: No
• Health authority: Ukraine: Coordination centre of transplantation of organs, tissues and cells
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2016
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Ukraine	Odessa Regional Clinical Hospital	Odessa

Sponsors (1)

Lead Sponsor	Collaborator
Odessa National Medical University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in global left ventricular ejection fraction and regional wall motion score index	Change in global left ventricular ejection fraction and regional wall motion score index.	6 and12 months	No
Secondary	Incidence of the major adverse cardiac events	Incidence of the major adverse cardiac events.	6 and 12 months	Yes