Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy in Patients With Post Myocardial Infarction Heart Failure (CardiAMP Heart Failure Trial)
This is a trial for patients who have had a heart attack in the past and have heart failure as a result. This trial will evaluate the effect of administering the patient’s own bone marrow stem cells directly into the most affected parts of the heart, compared with placebo, on heart function over time. Patients will be enrolled for one year.
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Randomized Controlled Pivotal Trial of Autologous Bone Marrow Mononuclear Cells Using the CardiAMP Cell Therapy system in Patients with Refractory Chronic Myocardial Ischemia (CardiAMP CMI Trial)
Despite improvements in revascularization techniques, there is a growing population of patients with chronic angina not amenable to further revascularization that suffer with severely limiting symptoms. Studies suggest that 5%-15% of patients undergoing cardiac catheterization have significant disease that is not able to be revascularized. Over the past few years, cardiovascular regenerative medicine using bone marrow derived cells has emerged as a new treatment strategy that could have tremendous benefit in treating ischemic heart disease, including chronic myocardial ischemia and refractory angina.
The purpose of this clinical trial is to determine the safety and efficacy of the CardiAMP cell therapy system in patients with chronic myocardial ischemia and refractory angina. Safety and efficacy of the CardiAMP cell therapy system will be compared with the sham control.
Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial): A Phase 1/2 Multi-Center, Open-Label Study to Evaluate Safety, Tolerability, and Efficacy
CAD is a chronic disease in which blood flow through the arteries that supply the heart with oxygen-rich blood is blocked. This leads to a restriction of blood supply to the heart, which is called ischemia. When blood flow to the heart is limited, the heart cannot get the oxygen and nutrients it needs to work properly. This causes chest pain or a pressure sensation that is felt in the chest, which is called angina.
The purpose of this study is to determine the safety of the experimental drug called XC001 in people suffering from angina caused by CAD who have no other treatment options. XC001 is designed to promote new blood vessels in the heart, with these new blood vessels bypassing the blockage in your coronary arteries and improving blood flow in your heart. XC001 is made of an adenovirus (one of the causes of the common cold), referred to as the vector, that has been genetically altered so it cannot reproduce and cause a cold. The vector is designed to seek out cells in your body and deliver a gene that allows those cells to create a new protein. This process is called gene transfer. Additionally, the vector has been changed so that it can carry parts of a gene called vascular endothelial growth factor or VEGF. VEGF is a gene that codes for growth factors that produce new blood vessels. XC001 is designed to deliver the gene by injections to the cells of the heart.
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