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Impact of Intracoronary Injection of Autologous BMMC for LV Contractility and Remodeling in Patients With STEMI

NCT02323620 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-01-23

No results posted yet for this study

Summary

This is multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a triple intracoronary infusion of autologous bone marrow-derived mononuclear cells in addition to state of the art treatment is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction (≤45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.

Conditions

Interventions

PROCEDURE

Intracoronary infusion of BM-MC

Bone marrow-derived progenitor cells are obtained from 60ml bone marrow aspirated from the iliac crest. Intracoronary infusion of the autologous cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique.

Sponsors & Collaborators

  • American Heart of Poland

    lead OTHER

Principal Investigators

  • Pawel E Buszman, MD, PhD · American Heart of Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-31
Primary Completion
2022-07-31
Completion
2022-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02323620 on ClinicalTrials.gov