Autologous Mesenchymal Stromal Cell Therapy in Heart Failure
Summary
It is a single centre, randomised controlled study of the effect of NOGA-guided direct intramyocardial injection of mesenchymal stromal cells on the development of new myocardium and blood vessels in patients with heart failure.
Stem cells will be obtained from the bone marrow and culture expanded for 6 - 8 weeks before injected into the myocardium.
The patients will be followed with safety, clinical, MRI and CT endpoints for 1 year.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Congestive Heart Failure
Intervention
Mesenchymal stromal cell, Saline
Status
Not yet recruiting
Source
Rigshospitalet, Denmark
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00644410
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Digoxin
A cardiotonic glycoside obtained mainly from Digitalis lanata; it consists of three sugars and the aglycone DIGOXIGENIN. Digoxin has positive inotropic and negative chronotropic activity. It is used to control ventricular rate in ATRIAL FIBRILLATION and in the management of congestive heart failure with atrial fibrillation. Its use in congestive heart failure and sinus rhythm is less certain. The margin between toxic and therapeutic doses is small. (From Martindale, The Extra Pharmacopoeia, 30th ed, p666)
Cardiotonic Agents
Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE).
Medigoxin
A semisynthetic digitalis glycoside with the general properties of DIGOXIN but more rapid onset of action. Its cardiotonic action is prolonged by its demethylation to DIGOXIN in the liver. It has been used in the treatment of congestive heart failure (HEART FAILURE).
Heart Failure
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.
Cardiomyopathy, Alcoholic
Disease of CARDIAC MUSCLE resulting from chronic excessive alcohol consumption. Myocardial damage can be caused by: (1) a toxic effect of alcohol; (2) malnutrition in alcoholics such as THIAMINE DEFICIENCY; or (3) toxic effect of additives in alcoholic beverages such as COBALT. This disease is usually manifested by DYSPNEA and palpitations with CARDIOMEGALY and congestive heart failure (HEART FAILURE).
Clinical Trials
An Australian Study of Mesenchymal Stromal Cells for Crohn's Disease
Despite the advent of newer biologic therapies such as infliximab for Crohn's disease, a form of autoimmune inflammatory bowel disease, a proportion of patients are refractory to such ther...
Congestive Heart Failure Surgical Treatmment With Autologous Stem Cell Therapy
This research study was designed to test the safety and effectiveness of autologous stem cell graft in the myocardium of patients with refractory Congestive Heart Failure (CHF) with ischem...
Treating Congestive Heart Failure Using a Device to Remove Cholesterol
A pilot study to examine the effects of LDL-Apheresis on patients with Stage III Congestive Heart Failure. Study hypothesis: Decreased blood viscosity from receiving LDL-apheresis will de...
The purpose of this study is to compare the effects on heart rate and ventricular arrhythmias (irregular heart beats) of two doses of Natrecor® (a recombinant form of the natural human...
Congestive Heart Failure: Causes of Sudden Worsening
The purpose of the study is to recognize main causes of acute decompensation of chronic congestive heart failure.
PubMed Articles
Reversible congestive heart failure in severe hypocalcemia.
We present a case of severe congestive left heart failure due to profound and long-term hypocalcemia caused by surgically induced hypoparathyroidism. Hypocalcemia as a potential contributor to heart f...
Captopril is well tolerated in most patients. There is no report of acute deterioration in renal function after administration of captopril in neonates with congestive heart failure secondary to conge...
Endothelin-1 levels in chronic congestive heart failure.
BACKGROUND: Endothelin-1 levels in patients with chronic congestive heart failure were evaluated with respect to the severity of cardiac dysfunction. The relationships between three neurohormones, bra...
Revisiting the cardio-renal hypothesis: the pivotal role of the kidney in congestive heart failure.
Prospects for gene transfer for clinical heart failure.
Congestive heart failure is an inexorable disease associated with unacceptably high morbidity and mortality. Preclinical results indicate that gene transfer using various proteins is a safe and effect...
