Brain Injuries Targeted for Adult Stem Cell Therapy

PRNewsWire.com, May 13, 2009

Dr. Feng Lin, director of research at Bio-Matrix Scientific Group and its subsidiary Entest Biomedical, believes that traumatic brain injury (TBI) could possibly be cured with autologous adult stem cells derived from adipose (fat) tissue.

According to Dr. Lin, "Currently there is no effective therapeutic approach to reverse the initial brain damage caused by trauma. Brain cells or neurons have limited ability for self-repair and spontaneous axonal regeneration. Extensive studies have been focusing on novel therapeutic strategies for traumatic brain injury. In my opinion, adipose-derived stem cells could possess the capacity for self-renewal and differentiation into diverse cell types such as neural cells. We could be looking at an exciting and potential cure for traumatic brain injury patients."

Both Bio-Matrix and Entest Biomedical are currently studying the ability of adipose-derived stem cells (ASCs) to regenerate damaged neurological tissue and to repair the inflammation and brain ischemia that result from TBI. Together, Bio-Matrix and Entest have recently submitted a research proposal to the U.S. Army Medical Research and Material Command (USAMRMC) for funding to investigate an ASC therapy for TBI, which is a common problem among U.S. soldiers returning from Afghanistan and Iraq, where roadside explosives are a frequent cause of TBI. According to reports from the Walter Reed Army Medical Center in Washington, D.C., sustained TBI is found in nearly a third of all returning soldiers who have combat injuries.

According to David Koos, chairman and CEO of Bio-matrix, "The objective of our proposal is to develop an effective ASC-based (adipose-derived stem cell) therapy for TBI. Specifically, we will substantially study the therapeutic effect of ASCs on TBI-associated brain ischemia and inflammation via intravenous administration or by intro-cerebral transplantation. It is plausible that our proposed study will pave the way for an ASC-based therapy for TBI, which hopefully will be much more feasible and safer than other stem cell-based approaches."

Headquartered in San Diego, Bio-Matrix Scientific Group is involved in the design and development of the next generation of medical devices and instrumentation including non-invasive bio-systems monitoring devices, adult stem cell cryogenics and instruments for tissue management. A wholly owned subsidiary of Bio-Matrix Scientific Group, Entest BioMedical is involved in the development of testing procedures for diabetes, and in the development of stem cell applications to diabetes and other diseases.

Every 15 seconds, throughout the world, someone suffers a brain injury. For people who suffer permanent brain injury, the average cost of lifetime care and rehabilitation is in the millions of dollars per person. According to one of the leading researchers in the field, Dr. Tracy McIntosh of the University of Pennsylvania School of Medicine, "Sadly, it is an epidemic that most people do not realize exists, and to date, there is no clinical treatment that can effectively treat the damage." Another leading researcher in TBI, Dr. Ronald Hayes, director of the University of Florida Brain Institute, concurs by stating, "Currently no effective treatment exists."

TBI affects more people than stroke or Alzheimer's disease combined. It is the leading cause of death in Americans under the age of 45, and it is also the leading cause of long-term neurological disability in children and young adults. According to the website of the National Institute of Neurological Disorders and Stroke (NINDS), a division of the National Institutes of Health (NIH), "Traumatic brain injury is a major public health problem, especially among male adolescents and young adults ages 15 to 24, and among elderly people of both sexes 75 years and older. Children aged 5 and younger are also at high risk for TBI." The Brain Injury Association of America defines TBI as follows: "A traumatic brain injury is defined as a blow or jolt to the head or a penetrating head injury that disrupts the function of the brain. Not all blows or jolts to the head result in a TBI. The severity of such an injury may range from 'mild', i.e., a brief change in mental status or consciousness, to 'severe', i.e., an extended period of unconsciousness or amnesia after the injury. A TBI can result in short or long-term problems with independent function."

Also known as "acquired brain injury", or simply "head injury", TBI is a type of "neurotrauma" that has been estimated to occur in approximately 1.5 million people per year in the United States alone. Of those, approximately 1.1 million cases per year are considered mild and are treatable in hospital emergency rooms, while approximately 235,000 cases per year are considered moderate and result in extended hospitalization, and approximately 50,000 cases per year are fatal. These figures are believed to be conservative estimates, as the actual number of people who sustain TBIs but who do not seek medical treatment is unknown. According to the U.S. Centers for Disease Control and Prevention (CDC), there are currently more than 5.3 million Americans who are living with some form of long-term or lifelong injuries that were incurred from TBI.

Reliable global statistics for TBI do not exist, although the World Health Organization has issued the following statement on the subject: "Neurotrauma is a critical public health problem that deserves the attention of the world's health community. Estimates of brain and spinal cord injury occurrence indicate that these injuries cause enormous losses to individuals, families, and communities. They result in a large number of deaths and impairments leading to permanent disabilities. Research has also shown that traumatic brain injury usually requires long-term care and therefore incurs economic costs to health systems. For this reason, many countries need to develop surveillance systems and conduct epidemiologic studies to measure the impact of neurotrauma among their people to guide the development of more effective preventive methods. A number of methods have already proven effective, such as the use of motorcycle helmets, head supports in vehicles or on sports equipment." Among members of the military who have been deployed to war zones, and also among reporters who are assigned to cover such wars, blasts are the leading cause of TBIs. For military medical personnel who may be involved in the triage, treatment, and transport of such combat-related injuries, a publication entitled "Guidelines for the Field Management of Combat-Related Head Trauma" is available from the Brain Trauma Foundation, at www.braintrauma.org. The guidelines were compiled by a group of civilian and military experts from the fields of neurosurgery, trauma and EMS who were assembled by the Brain Trauma Foundation for the specific purpose of formulating such guidelines that would address the particular nature of war-related head injuries. The publication was funded by the Defense and Veterans Brain Injury Center in collaboration with the Henry M. Jackson Foundation for the Advancement of Military Medicine. Among the civilian population of the U.S., approximately half of all TBIs are caused by motor vehicle traffic accidents, and approximately half of all TBIs involve the use of alcohol. Outside of war zones, therefore, TBIs are among the most preventable of injuries. Between the ages of 15 and 24, males are nearly twice as likely as are females to sustain a TBI. For people aged 75 and older, most TBIs are the result of falls. Approximately 20% of all TBIs are due to violence, and approximately 3% are the result of sports injuries. Over 90% of TBIs that are caused by the use of firearms result in death, whereas approximately 11% of TBIs that are caused by falls result in death. As of 1995, combined direct medical expenses and indirect costs such as lost productivity from work due to TBI was estimated at $56.3 billion in the United States.

Adult stem cell therapy offers the first type of treatment for TBI which can actually heal the injuries by regenerating damaged neurological tissue.

(Please see the related section on this website, entitled, "Traumatic Brain Injury", located under "Research").