"ESTIMATION Study" for Endocardial Mesenchymal Stem Cells Implantation in Patients After Acute Myocardial Infarction
NCT01394432 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2015-09-23
Summary
The investigators hypothesised that endocardial stem cells implantation following after percutaneous coronary intervention (PCI) could reduce the scar formation and increase reverse remodeling in patients with primary acute myocardial infarction.
Conditions
- Acute Myocardial Infarction
- Heart Failure
Interventions
- PROCEDURE
-
PCI and Stem Cells or Placebo injections
Conventional percutaneous coronary intervention after acute myocardial infarction. Harvest of bone marrow from iliac crest. Mesenchymal autologous stem cells preparation (7-10 days after PCI). LV mapping with Noga system (7-10 days after PCI). Randomization 1:1. Stem Cells or placebo implantation.
Sponsors & Collaborators
-
Meshalkin Research Institute of Pathology of Circulation
lead NETWORK
Principal Investigators
-
Evgeny A Pokushalov, MD, PhD · State Research Institute of Circulation Pathology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-07-31
- Primary Completion
- 2012-11-30
- Completion
- 2016-11-30
Countries
- Russia
Study Locations
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