Trauma

A Planned Phase 2 Clinical Study for Trauma

Trauma

In April 2018, The University of Texas Health Science Center at Houston (UTHealth) and Athersys announced plans to conduct a Phase 2 clinical trial evaluating MultiStem cell therapy for early treatment and prevention of complications after severe traumatic injury. This first-ever study of a cell therapy for treatment of a wide range of traumatic injuries will be conducted at Memorial Hermann-Texas Medical Center, one of the busiest Level 1 trauma centers in the United States.

In conjunction with this planned study, UTHealth reported that its McGovern Medical School has received a grant award from the Medical Technology Enterprise Consortium (MTEC) to support the study. The MTEC grant will provide funding for approximately 50% of the trial cost, with additional funding being provided by the Memorial Hermann Foundation. Athersys' support will include its cost of providing clinical product for the conduct of the trial and regulatory and operational support.

The objective of the clinical study is intended to evaluate the safety and effectiveness of MultiStem for the treatment of severely injured patients for the prevention and early treatment of complications after severe traumatic injury. The proposed study is anticipated to be a randomized, double-blind, placebo-controlled Phase 2 clinical trial estimated to enroll approximately 150 severely-injured trauma patients who have survived initial treatment and are admitted to the intensive care unit. These patients will be randomly assigned to receive MultiStem or placebo within hours of hospitalization, and both groups will receive standard care for their injuries. The proposed Phase 2 clinical trial must still go through review and approval by the U.S. Food and Drug Administration (FDA), and therefore, the design is subject to additional input.

According to the Centers for Disease Control (CDC), trauma is the leading cause of death for individuals under the age of 45 and the third leading cause of death in the United States, accounting for approximately 180,000 fatalities each year. It is also a leading cause of serious disability, especially among young people that suffer trauma and members of the military. The CDC reports that, in the most recent year evaluated, 2013, there were more than 2.5 million emergency department visits for traumatic brain injury (TBI) and more than 282,000 hospitalizations. Over 5 million people in the United States are living with a TBI-related disability, and an estimated 80,000 - 90,000 people suffer a serious disability from TBI each year in the United States at an estimated cost of $37.8 billion, annually.

Seventy-five percent of trauma-related deaths occur during the first three days after injury and are primarily due to uncontrolled bleeding and TBI. After three days, the remaining twenty-five percent of deaths occur at a low, but steady, rate and result from inflammation or immune complications, blood vessel damage, and poor clotting associated with the initial injury, shock and resuscitation. These inflammatory-related complications include acute kidney injury, acute respiratory distress syndrome, venous thromboembolic disease, multiple organ failure, neurological swelling and tissue death after TBI, as well as secondary infections.

Source: https://www.cdc.gov/traumaticbraininjury/get_the_facts.html