Clinical trial NCT01354678: Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia
Official title: Phase 1 Study to Evaluate the Efficacy and Safety of Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Heart Failure
Keywords: heart failure
bone marrow mononuclear cells
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2011-05-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomised placebo-controlled study of efficiency and safety of bone marrow mononuclear cells transplantation by intramyocardial multiple precision injection in ischemic heart failure patients.

Detailed description: The increase of prevalence of heart failure in human population requires to develop new and effective methods of treatment. One of them is stem cells transplantation into a myocardial tissue, which cause the improvement of contractility, myocardial remodelling after myocardial infarction (MI), dilated cardiomyopathy, etc. Use of autologous stem cells does not require of immunosuppressive therapy and does not correlate with some ethical problems. Clinical application of mesenchymal stem cells always requires a step of culturing, which is associated with increased risk of contamination Therefore haemopoietic stem cells, endothelial progenitor cells or mononuclear bone marrow cells are often used to be transplant for treatment of heart failure (HF) patients.Using NOGA XP Cardiac Navigation System improves specificity of transplantations, that is decisive.

Eligibility criteria: Inclusion Criteria:

* patients with coronary artery disease (CAD) and HF II-III NYHA class
* MI more than 6 months before the study
* LVEF less than 35%
* absence of indication to coronary revascularization
* 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

Primary outcomes:
measure: Change in global left ventricular ejection fraction and regional wall motion score index
timeFrame: 6 and12 months
Secondary outcomes:
measure: Incidence of the major adverse cardiac events
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Almazov Federal National Medical Research Centre
Study officials:
affiliation: Almazov Federal Heart, Blood and Endocrinology Centre
name: Eugene V Shlyakhto, Prof
role: PRINCIPAL_INVESTIGATOR
References: