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
About this trial
This is an interventional treatment trial for Heart Failure
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
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
NCT ID
NCT01615250
First Posted
June 6, 2012
Last Updated
June 8, 2012
Sponsor
Odessa National Medical University
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
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