Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy (ISCIC)

June 8, 2012 updated by: Iurii Kozlov, Odessa National Medical University

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
      • Odessa, Ukraine, 65025
        • Recruiting
        • Odessa regional clinical Hospital
        • Contact:
          • Iurii I Karpenko, Dr, PhD
          • Phone Number: +380487500115 +380487500115
          • Email: arcard2@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 and12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of the major adverse cardiac events
Time Frame: 6 and 12 months
Incidence of the major adverse cardiac events.
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odessa National Medical University

Investigators

  • Principal Investigator: Iurii I Karpenko, Dr, PhD, Odessa National Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ANTICIPATED)

January 1, 2015

Study Completion (ANTICIPATED)

January 1, 2016

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (ESTIMATE)

June 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 8, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISCIC-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Intramyocardial implantation of stem cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ghana

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe