November 2012

Miami Project Paralysis Cure Clinical Trials

Promising Paralysis Treatment May Start Human Trials Soon

Breakthrough research on human patients will move forward at the Miami Project to Cure Paralysis in the near future. The trial is the only one of its kind in the world and focuses on the Schwann cells, which are known to awaken neurons.

Dr. Barth Green and Nick Buoniconti, the father of Marc Buoniconti, who was paralyzed during a football game, started the Miami Project at the University of Miami 26 years ago.

“Every great journey starts with a first step. We’re here today to celebrate that first step,” said Nick Buoniconti.

In the study, millions of cells will be created from a piece of peripheral nerve with Schwann cells taken from the patient. Within five weeks, the new cells will be injected into the injured area of the spinal cord.

“They re-insulate the damaged fibers. The Schwann cells also make the injured spinal cord more permissive for regeneration. So these cells can also wake neurons up and get them to grow,” explains Dalton Dietrich, the Miami Project scientific director.

Miami Project Group photo

Despite the similarities in the procedure, these are not the same as stem cells. The cells must also be transplanted within 26 to 40 days after the injury. In phase one, the FDA researchers will test the safety in just eight patients that have very new injuries to the spinal cord.

“The fact that we can use a person’s own cells is extremely important and that’s been one of the most important factors that drive our research,” said Mary Bartlett-Bunge, who is heading the research.

“We are looking for patients between the ages of 18 and 50 who have sustained a thoracic spinal cord injury with complete paralysis in the legs and loss of sensation in the legs,” said ” UM neurosurgeon Dr. Allen Levi, the study’s principal investigator.

If the study shows that Schwann cell therapy is safe for use in the newly injured, the University of Miami will immediately apply to the FDA for permission to attempt the procedure in patients that have been injured longer.

“There are tens of millions of people out there who have brain injuries and other neurological degenerative diseases, and all of these people potentially can benefit from this ability to repair the central nervous system,” he said.

For our previous coverage on the Miami Project’s paralysis cure testing, see: “Geron Abandons Stem Cell Paralysis Cure, but the Miami Project Carries On.”


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Veterans Fertility After Disablity Not Covered by Pentagon

Pentagon Offers Little Help to Veterans with Genital Wounds

While generally the Pentagon provides benefits to soldiers who’ve suffered damage to their genitals from IEDs or other explosives during combat, many reproductive health benefits continue to remain elusive. For example, if a male soldier returns from battle with a wound that prevents him from reproducing, such as an explosion that destroys or completely removes his testicles, then he and his wife will not receive benefits from the U.S. government to fund an in vitro fertilization or artificial insemination from donor sperm.

The Defense Department adopted this policy, with no announcement, as a result of the overwhelming number of wounded soldiers who’ve expressed the belief that the government that sent them to war should provide them with the financial assistance they need to start families once they return. Over 1,800 veterans with genital wounds expressed this belief, and consequently, the Pentagon recently changed its policy regarding the amount of compensation and eligibility the government will provide wounded veterans who’ve had their genitals damaged.

Veterans Disabled in Battle Struggle with Fertility

At least one aspect of the policy at issue here is the eligibility of those who can expect to receive compensation. To explain, while the new policy allows limited in vitro fertilization and artificial insemination, it specifically does not provide benefits to those males who are unable to produce sperm.

According to the policy, “Third-party donations and surrogacy are not covered benefits.” For obvious reasons this policy has caused great concern, as it affects a significant number of individuals. For instance, according to a military study, the average age of veterans with genital wounds was 24 years, and 56% of those in the service were married.

Fertility Not Covered for Veterans with Disabilities

Also at issue here is the amount of compensation available for those who’ve suffered genital wounds or complete loss of reproductive capabilities. It would seem that the current policies of the Pentagon and the Department of Veterans Affairs don’t seem to add up for those who’ve suffered both catastrophic injuries as well as genital loss or damage. To explain, the current policy pays up to $100,000 to the severely wounded to help them finance accessibility needs (e.g., wheelchairs, making one’s home and car accessible). The policy also allots an additional $50,000 for those who’ve lost their genitals in combat. However, the issue here is that the VA has a cap on the amount of lifetime benefits a veteran may receive here, so once a veteran’s benefits exceeds the $100,000 mark for his amputations, he is unable to collect on the remaining $50,000 that he was allotted as a result of a his genital injury.

This additional benefit is critical to those with both amputation and genital injuries, as the costs of procedures such as in vitro fertilization or artificial insemination can be costly—easily $5,000. Furthermore, those veterans wishing to consider other means of starting families, such as adoption, find themselves faced with other financial hurdles, as the cost of adoption currently runs about $30,000. The high costs of these procedures and processes means that veterans, their spouses, and their future families could all benefit greatly from that additional $50,000.

Injured Veterans Uncovered for Fertility Treatment

Since 2005, the roadside bombs in Iraq and Afghanistan have caused over 34,000 U.S. casualties. Recent Pentagon data indicates that through May of this year, approximately 3,000 soldiers have died as a result of these bombs, and another 31,000 have been wounded. Of those wounded, some 1,800 troops suffered genital wounds.

These veterans already have a difficult time adjusting to civilian life as they must work through the complete devastation of having lost limbs. To further complicate matters, many wounded veterans return home from war only to find themselves unemployed or not able find work. Having to acknowledge the loss of one’s sexual capabilities can easily compound these difficulties for veterans–making the period of adjustment that much longer.

This past summer, Senator Patty Murray of Washington State introduced legislature to overturn the exclusion of fertility treatments for soldiers struggling with starting a family after disability. The Women Veterans and Other Health Care Improvements Act of 2012 is currently in committee and awaiting passage in the House and Senate. If this gains approval, many soldiers and their spouses could see their dreams coming true. We will keep you posted as we hear more.


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Prosthetic Bone Implant for Veteran Amputees

Amputee Veterans Get More Options with Prosthetic Implant

A team of researchers and surgeons from the University of Utah and the George E. Wahlen Department of Veterans Affairs Medical Center in Salt Lake City are working hard to address the needs of the thousands of wartime veterans returning home with limb amputations unable to support traditional prosthetics. Often these veterans have skin issues or lack ample remaining limb length to qualify for the standard socket-type attachment system.

The researchers have spent the last six years developing an alternate solution that involves osseointegrated direct skeletal attachment of prosthetic limbs. The device is implanted directly into the remaining bone, then passes through the skin so that a prosthetic limb cam be attached without the need for a socket. Nothing like this has been attempted before in the United States, and only 250 procedures have been attempted world wide, with mixed results.

“We are trying desperately to provide relief to the many veterans who have lost a limb,” says Roy Bloebaum, professor of orthopaedics at the University of Utah and the director of the VA Bone and Joint Research Lab. “Most of these people are very young and have many years to live. Our goal is to give them back all of the abilities they had before they were injured.”

Utah Researchers of Prosthetic Implant for Veterans

Recently, the researchers, which include Kent Bachus, an engineer, professor, and director of the Orthopaedic Research Lab at the University of Utah, and Peter Beck, an orthopaedic surgeon and adjunct professor of orthopaedics, partnered with DJO Surgical. DJO Surgical is a global developer and manufacturer of medical devices that has licensed the implant technology and is playing an active role in the remaining research and development.

The Food and Drug Administration accepted the device into a program that permits designing a human early feasibility study. DJO Surgical applied for the FDA study and will be responsible for managing the implementation of the study, which will last up to three years. During the three years, ten patients will have the device implanted. The team can develop and refine the device between each operation, which supporters hope will streamline the refinement process and compress the development cycle.

The three problems that must be overcome include getting the bone to grow into the device, preventing infection, and addressing the skin interface. The team of researchers believes they have overcome these problems by coating the titanium device with a porous titanium material called P2 (P squared), which allows skin and bone to grow into the material to form a secure bond.

“We are excited to sign this partnership agreement with the University of Utah and Dr. Bloebaum,” says Bryan Monroe, DJO’s senior vice president and general manager of DJO Surgical. “With the combination of our proprietary titanium P2 porous coating and Dr. Bloebaum’s unique approach for percutaneous osseointegrated prosthesis, we believe that we have developed a winning solution that will have a monumental impact on the lives of amputees.”

The three researchers have quite a way to go before hospitals will consider offering their implant prosthesis. They are working on securing $5 million in grants and other partnerships similar to the partnership with DJO Surgical, so they may fine tune and perfect the process and device.


Voters with Disabilities

Voters with Disabilities Still Face Accessibility Barriers

As many as 3.2 million Americans may have been “sidelined” from participating in this year’s presidential election day, despite 20 years of fighting for laws to boost access to the polls. Who are these people who may be denied the ability to access their polling location and vote? They are the nation’s citizens with disabilities.

The Americans with Disabilities Act and the Help America Vote Act require that polling places have accessible voting systems, and that they ensure equal access and participation for people with physical and visual disabilities, yet voter turnout for people with disabilities is still 11% lower than non-disabled voter turn-out. Some critics of the current election day system think that number may be enough to change the results of a close election. Part of the problem is a lack of motivation to vote, but part is also due to a lack of accessible polling places.

Standing Polling Stations in New York

New York City made headline news recently, when a Federal Court judge listened to testimony about how to make polling sites in New York City more accessible for people who use wheelchairs and have vision impairments. The lawsuit came on the heels of a U.S. District Court judge’s ruling from early August that conceded that there were pervasive barriers at the voting sites for people with disabilities.

Voting with Disabilities

That lawsuit was first filed two years ago, claiming that the Board of Elections has violated the Americans with Disabilities Act. The case presented a laundry list of challenges city residents with disabilities faced at polling places, including wheelchair ramps too narrow or steep, missing handicapped entrance signs, and voting booths too close to the wall for wheelchair access. While the ruling on the case was a victory for disabled voters, other areas of the country still face a litany of problems.

“The truth is that voting is a really symbolic act. And to be denied the right to vote in person at your polling place is to have your voice silenced, to be excluded from your community and from having a voice in your country,” explained Julia Pinover, one of the attorneys in the NYC case.

Disabilities Matter when Voting

New York is not alone in its “open to interpretation” form of disability discrimination. In 39 of the nation’s states, there are laws that disqualify voters deemed “mentally incompetent” by a court from having the right to vote.

For example, in Virginia, election officials refused to provide absentee ballots for people in state psychiatric facilities because they read state law to allow ballots only for people with physical disabilities. And in Philadelphia during the 2008 election, nursing home residents were denied the right to vote based on the nursing home’s assessment of the capacity to vote, despite the fact there are no Pennsylvania laws that require voters to be deemed competent in order to vote.

Voter Handicap Parking Signs

Health and Human Rights Advocacy Director Rebecca Schleifer at Human Rights Watch says, “According to a 2009 US Government Accountability Office study, more than two-thirds of polling places are not fully accessible; nearly 25 percent did not have equal access to a secret and independent ballot and voting in a polling place, considered the ‘hallmarks of an effective and informed right to vote,’ as voting-rights expert Michael Waterstone has noted.”

What was your experience in this year’s election? Were your polling places accessible? Did you or a loved one face any disability discrimination that impeded your right to vote?


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