Cell Therapy in Severe Chronic Ischemic Heart Disease

NCT01727063 | Completed Phase 3 DMC

• 1 other identifier: EMRTCC-ISQ2
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Ischemic Heart Disease; Coronary Artery Disease; Angina Pectoris

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Increase in myocardial perfusion

  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.

  1, 6 and 12 months

Secondary Outcomes (1)

• Improvement in LV function

  1, 6 and 12 months

Other Outcomes (1)

• Improvement in angina functional class

  1, 6 and 12 months

Study Arms (2)

Cell Therapy

EXPERIMENTAL

Intramyocardial injection of autologous bone marrow-derived cells

Procedure: Cell Therapy

Placebo

NO INTERVENTION

Saline injection

Interventions

Cell Therapy PROCEDURE

Intramyocardial injection of autologous bone marrow-derived cells

Cell Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, Brazil: lead

Study Sites (1)

Heart Institute

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (2)

• Tura BR, Martino HF, Gowdak LH, dos Santos RR, Dohmann HF, Krieger JE, Feitosa G, Vilas-Boas F, Oliveira SA, Silva SA, Bozza AZ, Borojevic R, de Carvalho AC. Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study. Trials. 2007 Jan 18;8:2. doi: 10.1186/1745-6215-8-2.

  PMID: 17233910 BACKGROUND

• Gowdak LHW, Schettert IT, Rochitte CE, de Carvalho LP, Vieira MLC, Dallan LAO, de Oliveira SA, Cesar LAM, Brito JOR, Guarita-Souza LC, de Carvalho ACC, Krieger JE. Additional improvement in regional myocardial ischemia after intracardiac injection of bone marrow cells during CABG surgery. Front Cardiovasc Med. 2023 Feb 7;10:1040188. doi: 10.3389/fcvm.2023.1040188. eCollection 2023.

  PMID: 36824456 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris; Myocardial Ischemia

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Jose Eduardo Krieger, MD, PhD

  Heart Institute

  STUDY DIRECTOR

• Carlos Eduardo Rochitte, MD, PhD

  Heart Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Coordinator

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

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: November 15, 2012
• Study Start: January 1, 2006
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: August 30, 2019

Record last verified: 2019-08

Locations

BR (1)