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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01615250
Other study ID # ISCIC-2012
Secondary ID
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


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
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