Study Stopped
Terminated due to inefficacy of the tested method
Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia
IMPI
Phase 1 Study to Evaluate the Efficacy and Safety of Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 heart-failure
Started May 2011
Longer than P75 for phase_1 heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 13, 2011
CompletedFirst Posted
Study publicly available on registry
May 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 13, 2020
February 1, 2020
7.4 years
May 13, 2011
February 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in global left ventricular ejection fraction and regional wall motion score index
6 and12 months
Secondary Outcomes (1)
Incidence of the major adverse cardiac events
6 and 12 months
Study Arms (2)
group of bone marrow cell therapy
ACTIVE COMPARATORgroup of sham therapy
SHAM COMPARATORInterventions
Intramyocardial multiple precision injection of bone marrow mononuclear cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Almazov Federal National Medical Research Centre
Saint Petersburg, 197341, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eugene V Shlyakhto, Prof
Almazov Federal Heart, Blood and Endocrinology Centre
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2011
First Posted
May 17, 2011
Study Start
May 1, 2011
Primary Completion
October 1, 2018
Study Completion
December 1, 2019
Last Updated
February 13, 2020
Record last verified: 2020-02