SALT LAKE CITY—For the 5 million Americans affected by heart failure, a heart transplant is often their only option for treatment—but a study underway at the University of Utah will test the safety of using a patient's own stem cells to treat ischemic and non-ischemic heart failure.
The one-year Cardiac Repair Cell Treatment of Patients with Dilated Cardiomyopathy (IMPACT-DCM) study will look at the safety of injecting Cardiac Repair Cells (CRC) and their ability to improve heart function, says Dr. Amit N. Patel, a national principal investigator for the study and director of cardiovascular regenerative medicine at the University of Utah School of Medicine.
Although there have been a number of small studies involving stem cells and heart failure, the IMPACT-DCM study is the first in the United States, an the first in the world to be randomized with both ischemic and non-ischemic cardiomyopathy, Patel notes. Ischemic heart disease occurs when hearts don't get enough blood and oxygen because of heart muscle damage caused by coronary artery disease, while non-ischemic heart disease, describes muscle damage caused by other means, including viruses or drug use.
"The early phases of bone marrow stem cells for heart disease have shown that they are very safe in the early years in properly selected patients," Patel says. "There have been over 2,000 patients in registered trials around the world. The early results are positive. Patients have the potential benefit of increased quality of life, decreased hospital admission and better exercise tolerance."
The researchers are currently enrolling patients who have been diagnosed with congestive heart failure (NYHA Class 3 or 4) and are between the ages of 18 and 86 for Phase II of the IMPACT-DCM trial. Patients enrolled in the trial will have 50cc of heir own bone marrow cells harvested, which will then be grown in a culture to expand the number of cells that will help the heart muscle and improve blood flow. Two weeks later, the patient's stem cells will be injected directly into the left ventricle of the heart during a minimally invasive surgery developed by Patel.
Most patients will leave the hospital two to three days after surgery and start to feel the results within six months, Patel says.
"By using a patient's own cells, we eliminate the concern of rejection and the need for potentially harmful immunosuppressive drugs," Patel says. "We hope these cells will help with new blood vessels and support the heart muscle in order to improve the heart's function, thereby greatly improving the patient's quality of life."
The trial is sponsored by Aastrom Biosciences Inc., a company specializing in autologous cell products. The potential commercial opportunity for a treatment developed by the trial is quite large, Patel notes.
"The current market for heart failure is 5 million patients, with 500,000 new diagnoses each year," Patel says. "It is number one in terms of the most expensive reason for hospitalization in the U.S." DDN
The one-year Cardiac Repair Cell Treatment of Patients with Dilated Cardiomyopathy (IMPACT-DCM) study will look at the safety of injecting Cardiac Repair Cells (CRC) and their ability to improve heart function, says Dr. Amit N. Patel, a national principal investigator for the study and director of cardiovascular regenerative medicine at the University of Utah School of Medicine.
Although there have been a number of small studies involving stem cells and heart failure, the IMPACT-DCM study is the first in the United States, an the first in the world to be randomized with both ischemic and non-ischemic cardiomyopathy, Patel notes. Ischemic heart disease occurs when hearts don't get enough blood and oxygen because of heart muscle damage caused by coronary artery disease, while non-ischemic heart disease, describes muscle damage caused by other means, including viruses or drug use.
"The early phases of bone marrow stem cells for heart disease have shown that they are very safe in the early years in properly selected patients," Patel says. "There have been over 2,000 patients in registered trials around the world. The early results are positive. Patients have the potential benefit of increased quality of life, decreased hospital admission and better exercise tolerance."
The researchers are currently enrolling patients who have been diagnosed with congestive heart failure (NYHA Class 3 or 4) and are between the ages of 18 and 86 for Phase II of the IMPACT-DCM trial. Patients enrolled in the trial will have 50cc of heir own bone marrow cells harvested, which will then be grown in a culture to expand the number of cells that will help the heart muscle and improve blood flow. Two weeks later, the patient's stem cells will be injected directly into the left ventricle of the heart during a minimally invasive surgery developed by Patel.
Most patients will leave the hospital two to three days after surgery and start to feel the results within six months, Patel says.
"By using a patient's own cells, we eliminate the concern of rejection and the need for potentially harmful immunosuppressive drugs," Patel says. "We hope these cells will help with new blood vessels and support the heart muscle in order to improve the heart's function, thereby greatly improving the patient's quality of life."
The trial is sponsored by Aastrom Biosciences Inc., a company specializing in autologous cell products. The potential commercial opportunity for a treatment developed by the trial is quite large, Patel notes.
"The current market for heart failure is 5 million patients, with 500,000 new diagnoses each year," Patel says. "It is number one in terms of the most expensive reason for hospitalization in the U.S." DDN
