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First Trial in the U.S. to Treat Both Ischemic & Non-Ischemic Heart Failure to be Performed by U of U Researchers Using Patient's Own Stem Cells
November 18, 2008Researchers at the University of Utah are enrolling people in a new clinical trial that uses 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.
Patients enrolled in IMPACT-DCM will have their own bone marrow cells drawn (about 3 tablespoons worth), 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 Amit N. Patel, M.D., national principal investigator for the IMPACT-DCM trial and director of cardiovascular regenerative medicine at the University of Utah School of Medicine.
"Heart failure affects about 5 million Americans, with more than half a million new cases diagnosed each year. A subset of these patients has dilated cardiomyopathy (DCM), a condition that leaves the heart weakened, enlarged and unable to pump blood efficiently. For most of these patients, the only option has been a heart transplant," said David A. Bull, M.D., professor and division chief of Cardiothoracic Surgery in the U's medical school and site principal investigator for the trial.
"This is the first trial of its kind in the United States, providing patients who have limited to no other options with a viable treatment," said Patel, professor of surgery. "By using a patient's own cells, we eliminate the concern of rejection and the need for potentially harmful immunosuppressive drugs. 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."
Patients who have been diagnosed with congestive heart failure (NYHA Class 3 or 4) and are between the ages of 18 and 86 may be eligible to participate in the trial. The University of Utah is one of five nationwide sites conducting the IMPACT-DCM study, sponsored by Aastrom Biosciences, Inc., a company specializing in autologous cell products. IMPACT-DCM is a randomized, controlled, Phase II study that will enroll 40 patients nationwide: 20 patients with ischemic DCM and 20 patients with nonischemic DCM.
For additional information on the IMPACT-DCM trial and eligibility, patients may call Patty Meldrum, R.N., research coordinator, at 801-581-5311.
University of Utah
"Heart failure affects about 5 million Americans, with more than half a million new cases diagnosed each year. A subset of these patients has dilated cardiomyopathy (DCM), a condition that leaves the heart weakened, enlarged and unable to pump blood efficiently. For most of these patients, the only option has been a heart transplant," said David A. Bull, M.D., professor and division chief of Cardiothoracic Surgery in the U's medical school and site principal investigator for the trial.
"This is the first trial of its kind in the United States, providing patients who have limited to no other options with a viable treatment," said Patel, professor of surgery. "By using a patient's own cells, we eliminate the concern of rejection and the need for potentially harmful immunosuppressive drugs. 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."
Patients who have been diagnosed with congestive heart failure (NYHA Class 3 or 4) and are between the ages of 18 and 86 may be eligible to participate in the trial. The University of Utah is one of five nationwide sites conducting the IMPACT-DCM study, sponsored by Aastrom Biosciences, Inc., a company specializing in autologous cell products. IMPACT-DCM is a randomized, controlled, Phase II study that will enroll 40 patients nationwide: 20 patients with ischemic DCM and 20 patients with nonischemic DCM.
For additional information on the IMPACT-DCM trial and eligibility, patients may call Patty Meldrum, R.N., research coordinator, at 801-581-5311.
University of Utah
Stem Cells Current Events and Stem Cells News RSSFirst reconstitution of an epidermis from human embryonic stem cells
Stem cell research is making great strides. This is yet again illustrated by a study carried out by the I-STEM* Institute (I-STEM/ Inserm UEVE U861/AFM), published in the Lancet on 21 November 2009. The I-STEM team, directed by Marc Peschanski has just succeeded in recreating a whole epidermis from human embryonic stem cells.
Bone Implant Offers Hope for Skull Deformities
A synthetic bone matrix offers hope for babies born with craniosynostosis, a condition that causes the plates in the skull to fuse too soon.
Your Own Stem Cells Can Treat Heart Disease
The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.
Is hepatic differentiation of embryonic stem cells induced by valproic acid and cytokines?
Embryonic stem (ES) cells, known for their capacity to proliferate indefinitely and differentiate into almost all types of cells including hepatocytes, have raised the hope of cellular replacement therapy for liver failure.
Paradoxical protein might prevent cancer
One difficulty with fighting cancer cells is that they are similar in many respects to the body's stem cells. By focusing on the differences, researchers at Karolinska Institutet have found a new way of tackling colon cancer. The study is presented in the prestigious journal Cell.
U of M researchers find 2 units of umbilical cord blood reduce risk of leukemia recurrence
A new study from the Masonic Cancer Center, University of Minnesota shows that patients who have acute leukemia and are transplanted with two units of umbilical cord blood (UCB) have significantly reduced risk of the disease returning.
The use of stem cells in regenerative medicine may also be detrimental for health
The use of stem cells in regenerative medicine is not always beneficial for human health, it may even be harmful according to a work done by the University of Granada and University of León. Scientists have demonstrated that transplantation of human mononuclear cells isolated from umbilical cord blood exerted a deleterious effect in rats with liver cirrhosis.
Penn Study Provides First Clear Idea of How Rare Bone Disease Progresses
An international team of scientists, led by researchers at the University of Pennsylvania School of Medicine, is taking the first step in developing a treatment for a rare genetic disorder called fibrodysplasia ossificans progressiva (FOP), in which the body's skeletal muscles and soft connective tissue turns to bone, immobilizing patients over a lifetime with a second skeleton.
Iowa State University researcher discovers key to vital DNA, protein interaction
A researcher at Iowa State University has discovered how a group of proteins from plant pathogenic bacteria interact with DNA in the plant cell, opening up the possibility for what the scientist calls a "cascade of advances."
Scientists successfully reprogram blood cells
Researchers have transplanted genetically modified hematopoietic stem cells into mice so that their developing red blood cells produce a critical lysosomal enzyme -preventing or reducing organ and central nervous system damage from the often-fatal genetic disorder Hurler's syndrome.
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