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First Japanese patient in TBI clinical trial enrolls

Randy Rozek • October 30, 2016

The first patient in Japan in a new clinical trial that studies regenerative cell medicine enrolled this week.

The trial, which is called the STEMTRA Phase 2 clinical trial is the world’s first global Phase 2 clinical trial of allogeneic stem cell medicine for traumatic brain injury.

“The STEMTRA trial is designed to study the safety, efficacy and tolerability of SB623 in patients with chronic motor impairments persisting at least twelve months following traumatic brain injury. It is being conducted across approximately 30 clinical trial sites in the United States and Japan. The first patient was enrolled in July, 2016, in the United States, and total enrollment is expected to reach 52 patients,” a press release in Business Wire reads.

Traumatic brain injury (TBI) is a complex injury with a broad spectrum of symptoms and disabilities. The impact on a person and his or her family can be devastating. TBI can result from a fall, sports injury, vehicle crash or combat-related incidents. Since our brain defines who we are, the consequences of a brain injury can affect all aspects of a person’s life, including their personality. A brain injury is different from a broken limb or punctured lung. An injury in these areas limit the use of a specific part of your body, but your personality and mental abilities remain unchanged. Most often, these body structures heal and regain their previous function.

Brain injuries do not heal like other injuries, according to traumaticbraininjury.com. Recovery is a functional recovery, based on mechanisms that remain uncertain. No two brain injuries are alike and the consequence of two similar injuries may be very different. Symptoms may appear right away or may not be present for days or weeks after the injury.

One of the consequences of brain injury is that the person often does not realize that a brain injury has occurred.

There are more than 5.3 million people living with disabilities resulting from traumatic brain injury in the United States alone. The trial is designed to demonstrate the efficacy and safety required to address this area of high unmet medical need, according to the press release.

“Damien Bates, Chief Medical Officer and Head of Research at SanBio said this is an important milestone for SanBio. ‘We’ve demonstrated that we can work with regulators to obtain approval for, and rapidly launch, a landmark clinical study for regenerative medicine in Japan,’” the release reads. “Japan grants marketing approval for regenerative medicines earlier than any other country, due to an amendment to the Pharmaceutical Affairs Law in 2014. This amendment introduced a conditional and term-limited Accelerated Approval system for regenerative medicine products and established Japan as a world leader in this field. SanBio intends to utilize Japan’s Accelerated Approval system upon the completion of the STEMTRA study to market SB623 in Japan prior to the rest of the world.”

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$8.3 Million Verdict in a Negligent Security Case for TBI and PTSD

By Randy Rozek • October 27, 2023
After an ongoing struggle to bring justice to the victim of an attack at a Wisconsin diabetes clinic, attorney Randy Rozek of Rozek Law Offices, S.C. has won an $8.3 million victory in which a jury found hospital security at fault for the attack and the client’s resulting injuries. In 2014, Rozek’s client was in the waiting room of the diabetes clinic at a local children’s hospital when a 16-year-old girl with a history of violence viciously assaulted her. The victim, who was accompanied by her two young children, was “punched repeatedly in the face and head, had chunks of hair pulled from her head and was struck in the head with a chair,” Rozek said. The children, aged 9 and 11 at the time, were so frightened by the brutal beating that they fled to a stairwell for safety, fearing their mother had been killed by the attacker and that they would be next if the attacker was to find them. Rozek’s client survived the assault, but still struggles with symptoms of a TBI (traumatic brain injury) and PTSD (post-traumatic stress disorder) following the attack.

Randy Rozek Elected Chair of the Traumatic Brain Injury Litigation Group

By Jayne Zabrowski • July 21, 2020
Congratulations to Attorney Randy Rozek on his election to be Chair of the American Association for Justice’s Traumatic Brain Injury Litigation Group. The American Association for Justice (AAJ) is the largest group of legal advocates for justice in the country. According to AAJ: “For over 70 years, AAJ has successfully defended Americans’ right to trial by jury and continues to fight every day to protect our practices, our clients’ rights, and our civil justice system.” The 3 pillars of AAJ are Community, Advocacy and Education. AAJ has over 50,000 members and has several different Litigation Groups made up of attorneys that specialize in different areas of the law. The Traumatic Brain Injury Litigation Group (TBILG) was established in 1991 in order to allow attorneys that handle Traumatic Brain Injury cases the ability to share their knowledge, techniques and experience. The TBILG has over 300 members from around the world. Pre-COVID19, the TBILG will typically put on two or three in-person conferences throughout the year and always had a reputation for bringing in great speakers and having a great turnout. Randy was asked about his election as Chair of the TBILG and had this to say: “It means a lot to me that my fellow trial lawyer colleagues bestowed upon my the great honor of leading the Traumatic Brain Injury Litigation Group for the next year. Our group is made up of some of the greatest TBI lawyers in the country, if not the world. I am proud to lead a group of great lawyers that have dedicated their practices to advocate for those individuals that have suffered from the devastating effects of brain injuries.” Rozek Law Offices, S.C. 3970 N Oakland Ave Ste 604 Milwaukee, Wisconsin 53211 (414) 374-4444 https://www.rozeklaw.com/

Rozek Law Offices Implements New Coronavirus Procedures

By Randy Rozek • March 18, 2020
The vast majority of interactions between clients and Rozek Law Offices is not in-person contact. Typically, however, the initial contact between a potential client and Attorney Rozek would be an in person meeting. Due to the health concerns regarding the Coronavirus (COVID-19), Rozek Law Offices has implemented new technology that will allow potential clients to retain Attorney Rozek and Rozek Law Offices without an in-person meeting. A typical new client relationship with Rozek Law Offices now looks like the following:

ATTORNEY RANDY ROZEK Selected for Brain Injury Preferred Attorney Program in WISCONSIN

By Randy Rozek • August 20, 2019
MILWAUKEE, WI – We are pleased to announce that Randy Rozek, Rozek Law Offices, S. C., has been selected to the Brain Injury Association of America’s Brain Injury Preferred Attorneys Program. This is an exclusive partnership between the nation’s oldest and largest brain injury advocacy organization and one of Wisconsin’s foremost brain injury law firms. […]

How Do You Get Your Clients?

By Randy Rozek • October 31, 2018
The majority of our clients are referred to us from people in the community, doctors, judges, lawyers, other past clients that we have represented, but also we’re routinely asked to associate with other attorneys around the state or even around the country because we know the right experts and we get the right results. Because […]

Wisconsin Rideshare Accident Lawyer

By Randy Rozek • October 8, 2018
Wisconsin Rideshare Accident Lawyer Rideshare accidents is a new field of law with the advent of Uber, Lyft, and other companies that offer ride services. What we’re seeing in the law is that some of these companies don’t provide adequate training or even adequate background checks on their drivers. Not only are we have seeing […]

Victims of Coma Lawyer in Milwaukee, Wisconsin

By Randy Rozek • October 3, 2018
Coma is a deep state of unconsciousness for a prolonged period of time, immediately following a coma or during a coma, the medical professionals are looking to eliminate the bleeding and eliminate the swelling of the brain. Following that, and even after the coma victim regains consciousness, they’re still likely going to be left with […]

What to Expect If You Have Been Referred to a Neuro Ophthalmologist

By Randy Rozek • September 7, 2018
If you’ve suffered a brain injury and you’re having vision problems, most likely, you’ll be referred to a neuro ophthalmologist. Some of the common visual disturbances following traumatic brain injury include light sensitivity, convergence disorder, blurred vision, seeing things in your visual field that aren’t actually there. A neuro ophthalmologist can help identify these types […]

What to Expect If You Have Been Referred to a Neuroradiologist

By Randy Rozek • August 20, 2018
A neuroradiologist is a radiologist that specializes in advanced imaging of the brain. If you’ve been referred to a neuroradiologist, they’ll do an MRI and then look for damage to certain parts of the brain. Most likely lesions in the gray-white matter interface, which is most susceptible to injury following brain injury. There will also […]

What to Expect If You Have Been Referred to a Neuroendocrinologist

By Randy Rozek • August 9, 2018
  If you’ve suffered a brain injury and you’ve been referred to a neuroendocrinologist, you can expect for that doctor to look for damage to your pituitary gland. If you’ve suffered a brain injury, most likely there was enough force involved to damage the pituitary gland or the hypothalamus, which connects the pituitary gland to […]
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