Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia (IMPI)
February 11, 2020 updated by: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Phase 1 Study to Evaluate the Efficacy and Safety of Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia
Randomised placebo-controlled study of efficiency and safety of bone marrow mononuclear cells transplantation by intramyocardial multiple precision injection in ischemic heart failure patients.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Saint-Petersburg, Russian Federation, 197341
- Almazov Federal National Medical Research Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 69 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: group of bone marrow cell therapy
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Intramyocardial multiple precision injection of bone marrow mononuclear cells
Other Names:
Intramyocardial multiple precision injection with placebo
Other Names:
|
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SHAM_COMPARATOR: group of sham therapy
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Intramyocardial multiple precision injection of bone marrow mononuclear cells
Other Names:
Intramyocardial multiple precision injection with placebo
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in global left ventricular ejection fraction and regional wall motion score index
Time Frame: 6 and12 months
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6 and12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Incidence of the major adverse cardiac events
Time Frame: 6 and 12 months
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6 and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eugene V Shlyakhto, Prof, Almazov Federal Heart, Blood and Endocrinology Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 1, 2011
Primary Completion (ACTUAL)
October 1, 2018
Study Completion (ACTUAL)
December 1, 2019
Study Registration Dates
First Submitted
May 13, 2011
First Submitted That Met QC Criteria
May 16, 2011
First Posted (ESTIMATE)
May 17, 2011
Study Record Updates
Last Update Posted (ACTUAL)
February 13, 2020
Last Update Submitted That Met QC Criteria
February 11, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IMPI-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.