Cell Therapy in Severe Chronic Ischemic Heart Disease

Last updated: August 28, 2019
Sponsor: Ministry of Health, Brazil
Overall Status: Completed

Phase

3

Condition

Circulation Disorders

Occlusions

Acute Pain

Treatment

N/A

Clinical Study ID

NCT01727063
EMRTCC-ISQ2
  • Ages 18-80
  • All Genders

Study Summary

Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization.

This study was designed to test the hypothesis that direct, intramyocardial injection of autologous bone marrow cells may further improve myocardial perfusion in patients undergoing incomplete bypass surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • symptoms of angina or angina equivalent

  • documented coronary artery disease (invasive angiography)

  • documented myocardial ischemia (stress echo, cardiac scintigraphy, or MRI)

  • unsuitable for complete myocardial revascularization (PCI or CABG) OR even if acomplete procedure in feasible, it is anticipated that myocardial perfusion may not berestored due to poor distal beds

Exclusion

Exclusion Criteria:

  • severe LV dysfunction (EF < 25% on echo)

  • short life expectacy (below < 1 year)

  • diagnosis of cancer in the past 5 years

  • diagnosis of hematological diseases

  • diagnosis of severe heart disease of other etiologies including valvular heartdisease, Chagas' disease, etc)

  • diagnosis of acute coronary syndrome in the past 3 months

  • diagnosis of chronic kidney disease stage V requiring chronic dialysis

Study Design

Total Participants: 143
Study Start date:
January 01, 2006
Estimated Completion Date:
July 31, 2018

Study Description

All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived cells (BMC) during surgery.

During follow-up, myocardial perfusion assessment will be performed to determine the improvement in treated areas compared to non-treated segments.

Connect with a study center

  • Heart Institute

    Sao Paulo, SP 05403-000
    Brazil

    Site Not Available

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