search
Back to results

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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Phase 1
Locations
Ukraine
Study Type
Interventional
Intervention
Intramyocardial implantation of stem cells
Sponsored by
Odessa National Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odessa Regional Clinical HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard therapy

Stem cells

Arm Description

Treatment with standard therapy. Cardiospec shock-wave therapy

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of the major adverse cardiac events
Incidence of the major adverse cardiac events.

Full Information

First Posted
June 6, 2012
Last Updated
June 8, 2012
Sponsor
Odessa National Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT01615250
Brief Title
Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odessa National Medical University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard therapy
Arm Type
No Intervention
Arm Description
Treatment with standard therapy. Cardiospec shock-wave therapy
Arm Title
Stem cells
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Intramyocardial implantation of stem cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in global left ventricular ejection fraction and regional wall motion score index
Description
Change in global left ventricular ejection fraction and regional wall motion score index.
Time Frame
6 and12 months
Secondary Outcome Measure Information:
Title
Incidence of the major adverse cardiac events
Description
Incidence of the major adverse cardiac events.
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iurii I Karpenko, Dr, PhD
Phone
+38048750113
Ext
+38048750113
Email
arcard2@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iurii I Karpenko, Dr, PhD
Organizational Affiliation
Odessa National Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odessa Regional Clinical Hospital
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iurii I Karpenko, Dr, PhD
Phone
+380487500115
Ext
+380487500115
Email
arcard2@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy

We'll reach out to this number within 24 hrs