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Status unknownNCT01615250ISCICUpdated Jun 11, 2012

Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy

A Phase 1 interventional study of Intramyocardial implantation of stem cells in Heart Failure, sponsored by Odessa National Medical University. Status unknown at 1 site in Ukraine. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-06-11.

Sponsored by Odessa National Medical University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
20 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Heart Failure

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03

In context

Cardiomyopathies

1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.

This study's planned enrollment of 50 is close to the median of 51 across 609 interventional studies indexed under Cardiomyopathies.

Browse Cardiomyopathies studies →

Lead sponsor

Odessa National Medical University is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • No intervention
    Standard therapy

    Treatment with standard therapy. Cardiospec shock-wave therapy

  • Active comparator
    Stem cells

    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.

    Biological: Intramyocardial implantation of stem cells

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 and12 months

Secondary outcomes

  1. Incidence of the major adverse cardiac events

    Incidence of the major adverse cardiac events.

    Time frame: 6 and 12 months

07

Study locations

1 of 1 sites recruiting
  • Odessa Regional Clinical Hospital
    Odessa, 65025, Ukraine
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01615250
Lead sponsor
Odessa National Medical University
Responsible party
Iurii Kozlov (Dr., PhD Iurii I Karpenko, Odessa National Medical University) — Principal investigator
First posted
Jun 8, 2012
Start date
Jan 2012
Primary completion
Jan 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Jun 11, 2012

Study contacts

Iurii I Karpenko, Dr, PhD
Contact
arcard2@gmail.com
+38048750113 ext. +38048750113
Iurii I Karpenko, Dr, PhD
principal investigator · Odessa National Medical University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.

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