Stem Cell Mobilization to Treat Chest Pain and Shortness of Breath in Patients With Coronary Artery Disease
CompletedPhase 2NCT00043628
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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)
This two-part study will determine whether stem cells (primitive cells produced by the bone marrow that can develop into blood cells or other types of cells) can be pushed out into the bloodstream, relocate in the heart, and grow new heart muscle and blood vessels in patients with chest pain caused by narrowing of their coronary (heart) arteries. The new blood vessels may enable patients to do more activities before experiencing chest pain. Part 1 of the study will evaluate in a small number of patients whether an increase in white blood cells following administration of G-CSF (a drug used to move stem cells from the bone marrow to the bloodstream) is safe in people with coronary heart disease. Part 2 will evaluate the effects of the circulating stem cells on heart function. Patients 21 years of age and older with coronary artery blockage that limits blood flow to the heart (as shown by coronary angiography within 6 months of entering the study) and causes chest pain that interferes with the ability to carry out daily living activities may be eligible for this study. Candidates will be screened with blood tests, an exercise test, magnetic resonance imaging (MRI), and 24-hour Holter monitoring of heart rate and rhythm. Participants will undergo the following tests and procedures: Part 1: Patients will be hospitalized at the NIH Clinical Center for 5 days. On the first day after admission, an indwelling catheter (short plastic tube) will be placed in an arm vein to avoid multiple needle sticks for blood sampling. Patients will then exercise on a treadmill. Blood samples will be drawn before the exercise test and 2 hours after the test. The next 2 days, patients will receive a daily injection of G-CSF under the skin. Blood samples will be drawn every day for 5 days to monitor the effect of G-CSF on moving cells into the bloodstream. Additional samples will be drawn to determine the effects of G-CSF on the number of stem cells that become heart cells, as well as any eff…
Study details
- Official title
- Stem Cell Mobilization as Therapy for Chronic Myocardial Ischemia in Patients With Coronary Artery Disease
- Conditions
- Interventions
- Procedure: Stem Cell Mobilization
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Organization
- National Institutes of Health Clinical Center (CC)
- Start date
- 2002-08
- Sex
- All
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
INCLUSION CRITERIA: Adults older than 21 years. Functional class (CCS) 3 or 4 angina attributable to atherosclerotic CAD, despite medical management, not optimal for mechanical revascularization due to coronary anatomy, co-morbidity, or patient preference. Left ventricular ejection fraction greater than 30 percent. Inducible myocardial ischemia by dobutamine stress MRI. No congestive heart failure symptoms within 2 months. No active infection. Normal renal function:creatinine less than 1.5 mg/dl, proteinuria less than 1plus Normal liver function: bilirubin less than 1.5 mg/dl, transaminases within normal limits. Normal blood count: WBC 3000-10000/microliter, granulocytes greater than 1500/microliter; platelet count greater than 150,000/microliter, Hgb greater than 12.5 g/dl. Subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations. EXCLUSION CRITERIA: Myocardial infarction within 2 months. Crescendo angina: Angina pectoris that is prolonged in duration (greater than 30 minutes), does not respond to nitroglycerin (3 tablets), or is occurring with increasing frequency over the previous two weeks. Significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, valvular heart disease) as determined by echocardiography. Patients who are HIV positive, have chronic inflammatory diseases, or are on chronic immunosuppressive medications. Women of childbearing age unless recent pregnancy test is negative. Lactating women. Known active malignancy or prior history of hematologic malignancy. Participation in unrelated research involving an investigational pharmacological agent 30 days before planned G-CSF dosing. Contraindication for MRI. Known hypersensitivity to E. coli-derived proteins or to gadolinium.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00043628