Cell Therapy in Severe Chronic Ischemic Heart Disease
CompletedPhase 3NCT01727063
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- 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
- Conditions
- Chronic Ischemic Heart Disease
- Coronary Artery Disease
- Angina Pectoris
- Interventions
- Procedure: Cell Therapy
- Sponsor
- Ministry of Health, Brazil
- Start date
- 2006-01
- Primary completion
- 2018-07
- Sex
- All
- Age range
- from 18 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Brazil
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01727063