Cell Therapy in Severe Chronic Ischemic Heart Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01727063

Acronym

MiHeart

Enrollment

143

Registered

2012-11-15

Start date

2006-01-31

Completion date

2018-07-31

Last updated

2019-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Angina Pectoris, Chronic Ischemic Heart Disease, Coronary Artery Disease

Keywords

Chronic ischemic heart disease, Coronary artery disease, Angina pectoris, Myocardial ischemia, Cardiac surgery

Brief 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.

Detailed 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.

Interventions

PROCEDURECell Therapy

Intramyocardial injection of autologous bone marrow-derived cells

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Intramyocardial injection of bone marrow-derived cells OR placebo (saline) during CABG

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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 a complete procedure in feasible, it is anticipated that myocardial perfusion may not be restored due to poor distal beds

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 heart disease, Chagas' disease, etc) * diagnosis of acute coronary syndrome in the past 3 months * diagnosis of chronic kidney disease stage V requiring chronic dialysis

Design outcomes

Primary

Measure	Time frame	Description
Increase in myocardial perfusion	1, 6 and 12 months	Patients will undergo myocardial perfusion assessment by MRI during pharmacological stress with adenosine or dipyridamole. Alternatively, cardiac scintigraphy can be used in patients with contra-indications to MRI.

Secondary

Measure	Time frame	Description
Improvement in LV function	1, 6 and 12 months	LV function (global and regional) will be assessed by MRI.

Other

Measure	Time frame	Description
Improvement in angina functional class	1, 6 and 12 months	Angina functional class will be determined using the Canadian Cardiovascular Society classification.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026