Dr. George Rappard’s Site is cleared to begin enrolling patients in new study. This clinical trial is the first U.S. study involving the use of the patient’s own stem cells, infused into the brain as a regenerative therapy, two weeks after a stroke.
Los Angeles, CA (PRWEB) March 18, 2011
“ALD-401 will be delivered about two weeks after a stroke; therefore for the first time, we are investigating a treatment option that we can extend to a broader number of patients without racing against the clock…”
Los Angeles, CA (PRWEB) March 18, 2011
The Los Angeles Brain and Spine Institute, directed by George Rappard, is the first to study brain stem cell infusion as a stroke treatment. The trial will be conducted using using Aldagen Inc’s ALD-401, a unique stem cell population derived from patient’s own bone marrow. Approximately ten sites will participate in this trial. It will be the first U.S. clinical trial in stroke patients to study the use of autologous stem cells that are infused into the brain as a regenerative therapy given two weeks after the stroke. The Principal Investigator at the Los Angeles Brain and Spine Institute (LABSI) is Dr. George Rappard, a Neurointerventional Surgeon, specializing in minimally invasive surgery of the brain and spine. The LABSI Co-investigators are Dr’s David Thompson, Lance Lee and Boris Bagdasarian.
“We are very excited to participate in such a groundbreaking clinical study. Stroke represents the leading cause of disability in the U.S. and is the third leading cause of death. Currently the treatment of stroke is limited to a small number of patients presenting early enough for clot busting drug or interventional therapy. Because these therapies are only effective if given within a few hours of a stroke, less than 5% of stroke patients receive the treatment. ALD-401 will be delivered about two weeks after a stroke; therefore for the first time, we are investigating a treatment option that we can extend to a broader number of patients without racing against the clock,” said Dr. Rappard.
The trial is designed to assess the safety of ALD-401 and its potential efficacy to improve clinical outcomes in patients with ischemic strokes when administered between 13 and 19 days after a stroke. The trial size will be approximately 100 patients, with roughly 60% receiving an injection of ALD-401 into the carotid artery, the artery supplying the majority of the brain on the side of the stroke. Only patients with unilateral cortical ischemic strokes will be eligible to participate in the clinical trial. In addition, the patient’s stroke must be at least moderate, but not severe.
About the Los Angeles Brain and Spine Institute
The Los Angeles Brain and Spine Institute provides state of the art comprehensive and minimally invasive brain and spine therapies, including supportive care and research. The Institute consists of a seasoned and experienced multi-disciplinary team. Our care is delivered in a compassionate and accessible community based setting.
Strokes are characterized by the rapidly developing loss of brain function due to a significant diminution in the blood supply to the brain. Strokes are typically classified into two major categories, ischemic and hemorrhagic. Ischemic strokes result from an inadequate supply of blood and oxygen to the brain due to blockage of an artery, such as by a blood clot, while hemorrhagic strokes result from rupture of a blood vessel or an abnormal vascular structure. The American Heart Association estimates that approximately 800,000 patients in the United States suffer a stroke each year, approximately 87% of strokes are ischemic, and the mean lifetime cost of ischemic stroke in the United States is approximately $140,000.
Aldagen is a clinical-stage biopharmaceutical company developing proprietary regenerative cell therapies. Aldagen’s product candidates consist of a specific population of a patient’s own stem cells, which are isolated using our proprietary technology and which has the potential to promote the regeneration of multiple types of cells and tissues, including the growth of new blood vessels. Aldagen’s initial focus is on developing product candidates to address cardiovascular disease. These clinical stage cardiovascular product candidates are ALD-301 for the treatment of critical limb ischemia, ALD-201 for the treatment of ischemic heart failure, and ALD-401 for the post-acute treatment of ischemic stroke.