Trauma

MATRICS-1 (MultiStem Administration for Trauma Related Inflammation and Complications)

A Phase 2 Trauma Study

In December 2020, Athersys and The University of Texas Health Science Center at Houston (UTHealth) announced patient enrollment in the MATRICS-1 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 is being conducted at Memorial Hermann-Texas Medical Center, one of the busiest Level 1 trauma centers in the United States.

In conjunction with this study, The University of Texas Health Science Center at Houston (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 is providing funding for approximately 50% of the trial cost, with additional funding being provided by the Memorial Hermann Foundation. Athersys' support includes its cost of providing clinical product for the conduct of the trial and regulatory and operational support.

The objective of the clinical study is 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 study is a randomized, double-blind, placebo-controlled Phase 2 clinical trial to enroll 156 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. 

Although the causes of traumatic injury are diverse, evidence suggests the hyperinflammatory response following these injuries is similar to other causes of acute tissue injury, such as acute ischemic stroke, acute respiratory distress syndrome (ARDS), traumatic brain injury and spinal cord injury. Activation and mobilization of the peripheral immune system after an injury contributes to local secondary tissue damage. This immune activation may also result in systemic inflammatory response syndrome (SIRS), which can leave the patient susceptible to a range of complications, including secondary infections and organ failure conditions, that prevent or complicate recovery. Results of pre-clinical injury models and clinical data from human trials in other indications suggest early administration of MultiStem cells may reduce the inflammatory cascade that ensues after severe acute injury by reducing the number of inflammatory systemic immune cells in and around sites of injury, and by decreasing immune cell activation and the release of inflammatory cytokines in response to circulating products of tissue injury. The study will evaluate whether MultiStem’s modulation of these immune responses to traumatic injury can mitigate secondary tissue injury, organ failure states, and other complications that impede patient recovery following severe traumatic injury. 


Similar to stroke and ARDS, traumatic injury often elicits an hyperinflammatory response. Listen as Dr. Busch describes Systemic Inflammatory Response Syndrome (SIRS).

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.

Trauma

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

Link: Car Accidents and Brain Injury Statistics 2020