The Long-term and Short-term Efficacy and Safety of Transplantation Autologous Bone Marrow Cells (BMCs) in Patients With the First STEMI (ST Segment Elevation Myocardial Infarction) (ESTABOMA)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vyacheslav Ryabov, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01748383
First received: December 7, 2012
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to test the hypothesis that the intracoronary transplantation of autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular contractile function and will reduce the combined end points after the primary STEMI (mortality, recurrent myocardial infarction, angina, heart failure, stroke).


Condition Intervention Phase
Vascular Diseases
Cardiovascular Diseases
Acute Myocardial Infarction
Procedure: Transplantation of BMMCs
Procedure: Transplantation of CD 133+ cells
Procedure: stenting of IRA
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Mononuclear and Cluster of Differentiation 133+ (CD 133+) Bone Marrow Cells, Growth Factors and Cytokines in the Remodeling of the Heart in Patients During and in the Late Periods After STEMI.

Resource links provided by NLM:


Further study details as provided by Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • Left ventricular ejection fraction (Echo) [ Time Frame: for an average of 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of cardiovascular death [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • incidence of the recurrent myocardial infarction [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • incidence of the angina [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • incidence of the heart failure [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • incidence of the stroke [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • incidence of the combined endpoint [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  • incidence and severity of adverse events [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 85
Study Start Date: September 2005
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transplantation of BMMCs
Autologous BMCs aspiration and transplantation of these cells
Procedure: Transplantation of BMMCs
The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. BMMCs were obtained by the method of the gradient centrifugation. Autologous BMMCs in the number 93±43 million transplantation by balloon catheter performed into IRA at once after stent implantation.
Experimental: Transplantation of CD 133+ cells
Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells
Procedure: Transplantation of CD 133+ cells
The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. Autologous CD133 + cells were obtained by the method of the magnetic separation. Phenotyping of the transplanted cells was performed by the cytofluorimetry. Autologous CD 133+ BMCs in the number 5,7 (0,45;9,0) million transplantation by balloon catheter performed into IRA at once after stent implantation.
Active Comparator: stenting of IRA
The only stenting of IRA
Procedure: stenting of IRA
The only stent implantation

Detailed Description:

The study was randomized, opened, controlled. 85 patients with the first STEMI were enrolled. Patients were divided to three groups. On admission all patients were received thrombolytic therapy by 1,5 million U streptokinase. Transplantation of autologous mononuclear bone marrow cells (BMMCs) and аutologous CD133 + cells by balloon catheter placed into infarct-related artery (IRA) was performed at once after stent implantation in 28 patients patients (1st group) and in 10 patients (2nd group) on the 7-21 days of STEMI. Another 47 patients (3nd group) undergo only stent implantation into IRA the same day of STEMI.

Autologous BMMCs were obtained from bone marrow aspirate by gradient centrifugation. Echocardiography, Holter monitoring were performed. Plasma concentration of the pro-inflammatory and anti-inflammatory cytokines (IL1, 6,8,10), of the growth factors (stem cell factor - SCF, vascular endothelial growth factor - VEGF, hepatocyte growth factor - HGF, fibroblast growth factor - FGF, insulin-like growth factor - IGF), the number of circulating CD34 +38-, CD133 +, СD117 +, CD90 +34- stem cells were determined in these patients in the acute and sub-acute myocardial infarction period.

It is going 7 years after the beginning of planned to evaluate left ventricular function of these patients, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, to evaluate the safety of transplantation of autologous BMCs (formation of intra-myocardial tumor or neoplastic processes of other sites) after 7 years from the beginning of study.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years and to 75 Years
  • Informed consent
  • First STEMI
  • Term admission to an intensive care unit in the first 24 hours of onset
  • Time reperfusion of the IRA is not earlier than 4 hours after the initial onset of acute transmural myocardial infarction

Exclusion Criteria:

  • Atrial fibrillation, a permanent form Valvular heart disease
  • Severe comorbidity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748383

Locations
Russian Federation
Scientific and Research Institution of Cardiology of Siberian Department of RAMS
Tomsk, Russian Federation, 634012
Sponsors and Collaborators
Russian Academy of Medical Sciences
Investigators
Principal Investigator: Vyacheslav Ryabov, MD, PhD Scientific and Research Institution of Cardiology of Siberian Department of RAMS
  More Information

No publications provided

Responsible Party: Vyacheslav Ryabov, Leading researcher of Emergency Cardiology Department, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01748383     History of Changes
Other Study ID Numbers: 99
Study First Received: December 7, 2012
Last Updated: December 13, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by Russian Academy of Medical Sciences:
Bone marrow cells
Acute myocardial infarction
Transplantation of autologous mononuclear
Transplantation of autologous CD133 + cells

Additional relevant MeSH terms:
Myocardial Infarction
Cardiovascular Diseases
Infarction
Vascular Diseases
Myocardial Ischemia
Heart Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on October 19, 2014