Autologous Bone Marrow Mononuclear Cells in the Combined Treatment of Coronary Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by St. Petersburg State Pavlov Medical University
Sponsor:
Information provided by (Responsible Party):
St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier:
NCT02059512
First received: February 1, 2014
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

The purpose of this study evaluate the effect of the method of administration of autologous bone marrow mononuclear cells for the duration of of functioning aorto-coronary bypass grafts in the surgical treatment of coronary heart disease, to assess the degree of effectiveness depending on the method of transplantation (intramyocardial, intracoronary).


Condition Intervention Phase
Ischemic Heart Disease
Procedure: coronary artery bypass grafting with administration of autologous bone marrow stem cells
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Influence of the Administration of Autologous Bone Marrow Mononuclear Cells for the Duration of Functioning Aorto-coronary Bypass Grafts in the Surgical Treatment of Coronary Heart Disease

Resource links provided by NLM:


Further study details as provided by St. Petersburg State Pavlov Medical University:

Primary Outcome Measures:
  • All-cause mortality associated with the progression of basic disease [ Time Frame: up to 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Percentage of functioning grafts in patients with implantation of autologous bone marrow mononuclear cells. [ Time Frame: up to 60 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: cell Therapy 1
intramyocardial administration of autologous bone marrow mononuclear cells during the operation coronary artery bypass grafting
Procedure: coronary artery bypass grafting with administration of autologous bone marrow stem cells
Placebo Comparator: non cell therapy
intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml
Active Comparator: cell therapy 2
intramyocardial and intracoronary administration of autologous bone marrow mononuclear cells during coronary artery bypass grafting
Procedure: coronary artery bypass grafting with administration of autologous bone marrow stem cells

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women from 18 to 80 years
  • Patients with angina pectoris III-IV functional class
  • Patients signed informed consent

Exclusion Criteria:

  • Intolerance of heparin and HES.
  • Hypothyroidism and hyperthyroidism.
  • Associated pathology with a projected lifespan limitation to 3 years.
  • infection diseases
  • Simultaneous participation in another study.
  • Pregnancy.
  • Severe mental disorder.
  • Refusal of a patient to participate in the study.
  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: NCT02059512

Contacts
Contact: Alexander S Nemkov, MD, Ph.D 8 921 795 00 47 nemk_as@mail.ru
Contact: Vladimir V Komok 8 904 632 19 00 vladimir_komok@mail.ru

Locations
Russian Federation
First Pavlov State Medical University of St. Petersburg Recruiting
St. Petersburg, Russian Federation, 197089
Contact: Alexander S Nemkov, MD, Ph.D    8 921 795 00 47    nemk_as@mail.ru   
Contact: Vladimir V Komok    8 904 632 19 00    vladimir_komok@mail.ru   
Sub-Investigator: Vladimir V Komok, Doctor         
Sub-Investigator: Sergey А Beliy, Doctor         
Sponsors and Collaborators
St. Petersburg State Pavlov Medical University
Investigators
Principal Investigator: Alexander S Nemkov, MD, Ph.D First Pavlov State Medical University of St. Petersburg.
  More Information

No publications provided

Responsible Party: St. Petersburg State Pavlov Medical University
ClinicalTrials.gov Identifier: NCT02059512     History of Changes
Other Study ID Numbers: NBK-2901-AMNKM
Study First Received: February 1, 2014
Last Updated: September 10, 2014
Health Authority: Russia: Ministry of Health of the Russian Federation

Keywords provided by St. Petersburg State Pavlov Medical University:
ischemic heart disease, autologous bone marrow mononuclear cells, coronary artery bypass grafting

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014