Archive for June, 2009
XenoPort, Inc. announced today that they have obtained positive results from their preliminary phase two trial of arbaclofen placarbil (XP19986) for the treatment of spasticity due to a spinal cord injury (SCI).
In today’s press release, XenoPort’s chief medical officer David A. Stamler said that “currently available medications for treating spasticity are often limited by their short duration of action and significant central nervous system side effects. The efficacy and tolerability of AP that were observed in this trial was encouraging, and we believe that AP offers the potential to address important medical needs for SCI patients.”
XenoPort is a biopharmaceutical company that is focused on the development of products that use the body’s “natural transport mechanisms” to improve existing drugs.
XP19986 showed no compelling negative side effects and demonstrated “significant improvements” in comparison with a placebo. It’s “designed to engage natural nutrient transport mechanisms found on intestinal cell membranes, thereby gaining efficient entrance into the bloodstream”, and XenoPort states that it could allow for just one or two needed doses in their future medial trials.
Muscle spasticity can cause many different conditions from an inability to walk to difficulty speaking due to stiffened muscles. If this drug withstands further trials, it may be able to benefit those who are suffering from spasticity caused by a spinal cord injury.
Image from here.
The ABC News Medical Unit asks an important question: Can a brain injury lead to death years after it occurs?
One example they provide is of Timothy Whalen’s recent death from unknown causes. According to ABC, officials are investigating the possible link between his death and a traumatic brain injury that he sustained eight years ago.
The article goes on to say that “in fact, research shows that those who suffer from the most severe brain injuries are statistically more likely to die early — from a variety of causes”.
ABC quotes Dr. Steven Flanagan, director of The Rusk Institute of Rehabilitation Medicine at the New York University Langone Medical Center in New York City as saying “there are a couple of lines of evidence to suggest that after a particularly acute brain injury that you have shorter life expectancy, even if you survive the acute injury phase”.
There are a handful of studies that seem to validate this view, but it’s difficult to create a direct correlation between a traumatic brain injury and a death years later. With Whalen’s autopsy still in the future, the jury is still out on this one.
A recent WCTV.tv interview discusses a new study for restoring bladder control in patients with spinal cord injuries.
The Xiao procedure, named for Professor Xiao, a urologist, splices a functioning nerve from the patient’s leg to the non-functioning one that is supposed to control bowel and bladder function.
The resulting “reflex arc” allows an injured patient to regain control of the elimination process.
According to the WCTV.tv interview, Professor Xiao was able to restore up to 80% functionality in his Chinese patients.
If current and future studies find similar results without any prohibitive side effects, this procedure has the potential to greatly increase the quality of life for those with spinal cord injuries.
A clinical trial to evaluate this procedure is currently being conducted at the All Children’s Hospital.
Bangalore’s BGS Global Hospital claims to have successfully used transplanted bone marrow stem cells to reactivate brain cells.
Madhumalika, 27, suffered a “diffuse axonal brain injury” after a “road accident” on December 14, 2008. Due to the severity of her head trauma, Madhumalika was in a coma for more than three months and had been given a 20 percent chance of survival. Diffuse axonal injuries are one of the most common types of traumatic brain injuries (TBI). They tend to affect a larger portion of the brain, and are one of the leading causes of death in those with a TBI.
“The patient was suffering from altered sensorium, severe cognitive dysfunction and lack of movement in limbs. Following the surgery, she has now regained full consciousness, memory, communication abilities and purposive movements in limbs,” N K Venkataramana, Chief neurosurgeon of BGS Hospitals, told reporters.
According to Venkataramana, this was the first procedure of its kind in India and only the second in the world. China made the first attempt, but if they showed similar results, they have stayed pretty quiet about it. (There are studies, such as this one and this one performed on rats, showing different types of brain injuries improving with stem cell transplants.)
A month after transplanting more than four million stem cells into the patient’s brain, Madhumalika regained her ability to talk, move her limbs, and recognize her family and friends.
Dramatic results? We think so! However, as with any new procedures, it’s smart to watch for further tests and examples of its effectiveness. There is very little data available at this point, and until more extensive research is provided, we curbing our excitement.
Venkataramana says that Madhumalika’s recovery has proven that brain injuries are curable, “Since 2004, there has been a pressing need to help the rising number of people who were disabled following road accidents. Stem cell therapy was one of the means to face the situation,” he said. He also notes that there are plans for a pilot study in the future.
We will be keeping our eyes open for more developments – the potential for a “brain injury cure”, while sounding almost too good to be true, is worth watching.
Image from here.
If you are in the Denver, Colorado area next week, be sure to check out the 3rd annual National Brain Injury Employment Conference on June 17th and 18th at the Red lion Hotel Denver Southeast.
The conference will last two days and feature speakers discussing topics that will help people with brain injuries obtain work-related resources. There are a multitude of factors that influence someone’s ability to find a job, continue a career, and do it successfully even without an injury, but those whose lives have been irrevocably changed from a brain injury face challenges that aren’t often addressed.
This even will be an opportunity for networking, exchanging ideas, and learning from experts in related recovery and workforce integration fields. A list of presenter biographies can be found here.
To register, call Call 1-800-733-5466.
Image from here.
The Sarah Jane Brain Foundation deserves some serious kudos for this one. It’s been the driving force behind the creation of the National Pediatric Acquired Brain Injury Plan (PABI Plan). The PABI Plan, unveiled today in Washington, is being called “the largest collaborative effort in the history of medicine”.
The History of PABI and Sarah Jane
Patrick Donohue of New York founded the Sarah Jane Brain Foundation (SJBP) in 2007 after his infant daughter sustained traumatic brain injury (TBI) when she was shaken violently by a nurse. Today she is unable to talk, crawl, or sit up.
The Sarah Jane Brain Project’s mission is “to create a model system for children suffering from all Pediatric Acquired Brain Injuries (PABI)”. Its leading efforts to expand research, develop protocols, and build awareness of PABI. To this end, in January 2009, the SJBP brought together more than 60 of the top pediatric neurologists in the country to draft the PABI Plan, the first of its kind.
The PABI Plan calls for the development of a “seamless, standardized, evidence-based, national system of care universally accessible for all children/young adults and their families regardless of where they live in the country”.
Fifty-two institutions have been selected through an open application process – one from each state plus the District of Columbia and Puerto Rico – to become the State Lead Centers. Selected by a committee of seven prominent brain scientists and rehabilitation experts, these State Lead Centers will be responsible for developing the master plan of acute care for children and young adults with brain injuries for their respective states.
Why is PABI Important?
According to the SJBP, more than a million children are hospitalized every year in the U.S. because of an acquired brain injury, with 17,000 suffering permanent disability and 5,000 dying from their injuries.
To paint a clearer picture – the World Health Organization reported that twice as many children suffered a brain injury than received stitches in 2008. In addition, the Centers for Disease Control and Prevention have estimated the financial burden of pediatric brain injury to cost more than $12 billion per year.
The SJBP website states that most brains aren’t fully developed until the age of 25, making many of the U.S.’s Iraq and Afghanistan veterans victims of Pediatric Traumatic Brain Injuries (PTBI). PABI includes more than just traumatic brain injury cases; it encompasses injuries caused by everything from brain tumors to substance abuse.
PABI calls for spending $125 million per year on work to ensure that U.S. children with brain injuries are provided needed care – from medical treatment to developmental therapies.
How can you help?
This plan will depend on the amount of federal stimulus funds and other funding it receives, and you can help by making a donation on the SJBP website, www.thebrainproject.org.
What is Entest BioMedical?
Entest BioMedical, Inc., formed in April 2009, is a subsidiary of bio-Matrix Scientific Group, Inc. Bio-Matrix is an interesting company. They provide stem cell storage for future use using cryogenics (the resurrection scene from Demolition Man is flashing through my head) as well as “stem cell related” services.
Entest focuses on research and development of ” autologous adipose-derived” for traumatic brain and spinal cord injuries.
“Our new Web site demonstrates Entest BioMedical’s mission and key scientific personnel who are dedicated to discovering and developing new procedures, treatments and medical devices that improve the quality of life – leading research and technology that serve the present and help shape the future,” said David Koos, Ph.D., DBA, Chairman and CEO in a recent press release for Entest.
How do they propose to help traumatic brain and spinal cord injuries?
Entest intends to use adipose-derived (read “fat derived”) stem cells (ASCs) that are taken from the fat that is vacuumed out during the liposuction process. It’s not clear who the patients are that will be donating their fat or from what specific lipo procedure the ASCs will come from. Whatever the source, Entest should be able to avoid the anti-stem cell furor with this approach.
According to the Entest website fat tissue is “the most abundant and accessible source of adult stem cells”. Considering that more than 800,000 liposuction procedures are performed every year, the decision to utilize this resource doesn’t come as a surprise!
These adult stem cells can “differentiate into neural cells” meaning that they are able to divide and change into the more complex neural cell type. These neural cells have a healing effect on the restricted blood supply, inflammation, and damaged neurons often caused by a traumatic brain injury (TBI) or spinal cord injury (SCI).
What have they discovered so far?
Entest states that “there is no effective therapeutic approach to reverse the initial brain damage caused by trauma because …cells have limited ability for self-repair…”. At this time, they have just begun the to develop their ASC-based therapy and won’t know how effective it is until the research is fully underway.
What are they doing now?
Entest submitted a Project Summary Reportto the U.S. Army Medical Research and Materiel Command (USAMRMC) in May 2009. They hope to receive some funding for their research as combat-related SCIs and TBIs continue to rise due to prevalence of explosives (roadside bombs especially) in Iraq and Afghanistan.
Let’s hope that Entest’s efforts will pay off! Safer, more effective approaches are needed, and needed now.
Adipose image from here.
