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Clinical Trials/NCT01615250
NCT01615250UnknownPhase 1

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

Odessa National Medical University2 sites in 1 country50 target enrollmentStarted: January 2012Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Enrollment
50
Locations
2
Primary Endpoint
Change in global left ventricular ejection fraction and regional wall motion score index
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Change in global left ventricular ejection fraction and regional wall motion score index

Time Frame: 6 and12 months

Change in global left ventricular ejection fraction and regional wall motion score index.

Secondary Outcomes

  • Incidence of the major adverse cardiac events(6 and 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Iurii Kozlov

Dr., PhD Iurii I Karpenko

Odessa National Medical University

Study Sites (2)

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