ISCIC: Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy

• Sponsor: Odessa National Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01615250
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Duration (Months): 48
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Biological: Intramyocardial implantation of stem cells	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2012
• Anticipated Primary Completion Date: Jan 1, 2015
• Anticipated Study Completion Date: Jan 1, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in global left ventricular ejection fraction and regional wall motion score index [6 and12 months]

   Change in global left ventricular ejection fraction and regional wall motion score index.

Secondary Outcome Measures

1. Incidence of the major adverse cardiac events [6 and 12 months]

   Incidence of the major adverse cardiac events.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: 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:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odessa Regional Clinical Hospital	Odessa		Ukraine	65025

Sponsors and Collaborators

• Odessa National Medical University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Iurii Kozlov, Dr., PhD Iurii I Karpenko, Odessa National Medical University
• ClinicalTrials.gov Identifier: NCT01615250
• Other Study ID Numbers: ISCIC-2012
• First Posted: Jun 8, 2012
• Last Update Posted: Jun 11, 2012
• Last Verified: Jun 1, 2012

• Additional relevant MeSH terms: Cardiomyopathies

Study Results

No Results Posted as of Jun 11, 2012