Benzinga | Dec 21, 2020 06:03AM EST

UTHealth in Houston and Athersys Announce Commencement of Patient Enrollment in a Phase 2 Trial Evaluating MultiStem Cell Therapy in Trauma

The University of Texas Health Science Center at Houston (UTHealth) and Athersys, Inc. (NASDAQ:ATHX) announced today that the first patient has been enrolled in a clinical study evaluating MultiStem(r) cell therapy for the potential early treatment of traumatic injuries and the subsequent complications that result. The MATRICS-1 (MultiStem Administration for Trauma Related Inflammation and Complications) study is being conducted at Memorial Hermann-Texas Medical Center, one of the busiest Level 1 trauma centers in the United States.

The Phase II randomized, double-blinded, placebo-controlled study is being funded by a grant award from the Medical Technology Enterprise Consortium (MTEC) awarded to McGovern Medical School at UTHealth. In addition, the Memorial Hermann Foundation is providing additional funding. Athersys is the trial sponsor and is supplying the investigational clinical product for the conduct of the trial, as well as providing regulatory and operational support. Dr. Charles S. Cox Jr., the George and Cynthia Mitchell Distinguished Chair in Neurosciences in the Department of Pediatric Surgery at McGovern Medical School at UTHealth and co-Director of the Red Duke Trauma Institute at Memorial Hermann-Texas Medical Center, is serving as the principal investigator.

The objective of the clinical study is to evaluate the safety and efficacy of MultiStem in the treatment of injured patients with severe hemorrhage for the prevention and mitigation of complications that can result following severe traumatic injury. The single-center trial will enroll up to 156 subjects. Subjects will be randomized and administered either placebo or MultiStem cellular therapy following admission to the intensive care unit and after initial resuscitation has concluded and stabilizing procedures have been performed to stop bleeding. All study subjects will also receive all standard of care treatments for their injuries.

"The use of this treatment strategy leverages a long legacy of investigation into the common mechanism of action of down-regulation of the inflammatory response to injury and how it mitigates complications of trauma," commented Dr. Charles S. Cox Jr., Principal Investigator at UTHealth.

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.

"Prior research conducted in collaboration with UTHealth suggests that administration of MultiStem following traumatic injury has the potential to downregulate the resultant hyperinflammatory cascade, and upregulate key repair mechanisms, improving overall recovery. Athersys is very appreciative of the support provided by MTEC and the Memorial Hermann Foundation for the conduct of this study and the tremendous amount of hard work and effort we've experienced in this collaboration with researchers, clinicians and staff at UTHealth," commented Dr. Robert W. Mays, Vice President of Regenerative Medicine and Head of Neuroscience Programs at Athersys. "We are pleased to enroll the first patient and look forward to evaluating the effects of MultiStem cellular therapy on patient outcomes. Severe trauma and the related downstream pathologies it can initiate is a clear unmet medical need of significance."

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 U.S., accounting for approximately 180,000 fatalities each year. It is also a leading cause of serious disability, especially among young people and members of the military that suffer trauma. According to independent research there are more than 31 million non-fatal injuries treated in U.S. hospitals each year.1

Athersys released an educational video today to provide additional information about this first-ever clinical study evaluating a cell therapy for treatment of traumatic injuries. The video features interviews with the clinical investigators that will be participating in the trial and other key personnel at Athersys. The video may be assessed from the Athersys website at www.athersys.com or at the following YouTube link: https://youtu.be/qyxn2Z78aW0

1Zonfrillo, M.R., Spicer, R.S., Lawrence, B.A. et al. Incidence and costs of injuries to children and adults in the United States. Inj. Epidemiol. 5, 37 (2018). https://doi.org/10.1186/s40621-018-0167-6