Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia (IMPI)
This study is currently recruiting participants.
Verified January 2012 by Almazov Federal Center of Heart, Blood and Endocrinology
Sponsor:
Almazov Federal Center of Heart, Blood and Endocrinology
Information provided by (Responsible Party):
Almazov Federal Center of Heart, Blood and Endocrinology
ClinicalTrials.gov Identifier:
NCT01354678
First received: May 13, 2011
Last updated: January 24, 2012
Last verified: January 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Randomised placebo-controlled study of efficiency and safety of bone marrow mononuclear cells transplantation by intramyocardial multiple precision injection in ischemic heart failure patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Procedure: NOGA XP Cardiac Navigation System |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 1 Study to Evaluate the Efficacy and Safety of Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia |
Resource links provided by NLM:
Further study details as provided by Almazov Federal Center of Heart, Blood and Endocrinology:
Primary Outcome Measures:
- Change in global left ventricular ejection fraction and regional wall motion score index [ Time Frame: 6 and12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of the major adverse cardiac events [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2015 |
| Estimated Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: group of bone marrow cell therapy |
Procedure: NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection of bone marrow mononuclear cells
Other Name: Cordis Corporation's Biologics Delivery Systems
|
| Sham Comparator: group of sham therapy |
Procedure: NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection with placebo
Other Name: Cordis Corporation's Biologics Delivery Systems
|
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| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354678
Locations
| Russian Federation | |
| Almazov Federal Heart, Blood and Endocrinology Centre | Recruiting |
| Saint-Petersburg, Russian Federation, 197341 | |
| Contact: Dmitry S Lebedev, Prof +78127023537 lebedevdmitry@mail.ru | |
| Contact: Olga M Moiseeva, Prof +78127026816 moiseeva@almazovcentre.ru | |
| Sub-Investigator: Dmitry V Kryzhanovsky, PhD | |
| Sub-Investigator: Sergey V Anisimov, PhD | |
Sponsors and Collaborators
Almazov Federal Center of Heart, Blood and Endocrinology
Investigators
| Principal Investigator: | Eugene V Shlyakhto, Prof | Almazov Federal Heart, Blood and Endocrinology Centre |
More Information
No publications provided
| Responsible Party: | Almazov Federal Center of Heart, Blood and Endocrinology |
| ClinicalTrials.gov Identifier: | NCT01354678 History of Changes |
| Other Study ID Numbers: | IMPI-1 |
| Study First Received: | May 13, 2011 |
| Last Updated: | January 24, 2012 |
| Health Authority: | Russia: Ethics Committee |
Keywords provided by Almazov Federal Center of Heart, Blood and Endocrinology:
|
heart failure bone marrow mononuclear cells |
Additional relevant MeSH terms:
|
Myocardial Ischemia Coronary Artery Disease Heart Failure Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013