Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy
ISCIC
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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 heart-failure
Started Jan 2012
Longer than P75 for phase_1 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 6, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJune 11, 2012
June 1, 2012
3 years
June 6, 2012
June 8, 2012
Conditions
Outcome Measures
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.
6 and12 months
Secondary Outcomes (1)
Incidence of the major adverse cardiac events
6 and 12 months
Study Arms (2)
Standard therapy
NO INTERVENTIONTreatment with standard therapy. Cardiospec shock-wave therapy
Stem cells
ACTIVE COMPARATORGroup of of intramyocardial implantation of peripheral mononuclear cells with CD34+ stem cells in patient with ischemic cardiomyopathy after preparatory course of shock - wave therapy.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odessa Regional Clinical Hospital
Odesa, 65025, Ukraine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iurii I Karpenko, Dr, PhD
Odessa National Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr., PhD Iurii I Karpenko
Study Record Dates
First Submitted
June 6, 2012
First Posted
June 8, 2012
Study Start
January 1, 2012
Primary Completion
January 1, 2015
Study Completion
January 1, 2016
Last Updated
June 11, 2012
Record last verified: 2012-06