Trauma is the leading cause of death for individuals under 45 and the third leading cause of death within the entire U.S. population. Of the approximately 180,000 trauma fatalities each year, up to 20% of them are potentially preventable.
Three quarters (75%) of trauma deaths occur during the first three days after injury, primarily due to uncontrolled hemorrhaging and traumatic brain injury (TBI). After the initial three days, the remaining 25% of trauma deaths accumulate at a low, but steady rate and result from a complex interplay of inflammation, vascular compromise and dysfunctional coagulation associated with the initial tissue injury, shock, and resuscitation.
Clinical manifestations of trauma include acute kidney injury (AKI), acute respiratory distress syndrome (ARDS), venous thromboembolic disease (VTE), multiple organ failure (MOF), and cerebral edema and ongoing cellular death after TBI. Current treatments for these inflammatory conditions are supportive, and efficacy trials for new interventions have all failed. Consistent and robust evidence supports the positive impact of rapid treatment for severe injuries, including restoration of perfusion, oxygen delivery, and wound coverage. However, achieving rapid damage control and definitive surgical treatment may prove impossible in future combat theaters. As a result, the military requires therapies that can mitigate the potential impacts of severe injuries and related delays of surgical interventions in order to prevent mortality from combat wounds.
Pre-clinical (and some limited clinical) data support the hypothesis that cellular therapies may be of use in mitigating the effects of severe injury. Numerous studies have documented improved organ function, reduced secondary organ (e.g. lung, kidney) injuries, and improved survival with cellular therapy. In response to these and other findings supporting the potential utility of cellular therapies, industry and academic institutions have developed prototype cellular therapy products requiring further assessment in well-designed clinical studies to refine and advance these trauma therapeutics.
This project award to the University of Texas Health Science Center, Athersys, Inc., and Memorial Hermann Hospital supports a Phase II clinical study to evaluate the safety and efficacy of cellular therapy in the treatment of hemorrhagic shock in severely injured patients. The research project award recipient was selected from among the offerors who responded to MTEC’s Request for Project Proposals (17-03-CTTHS).
Stem Cells for the Prevention of Inflammatory Complications of Severely Injured Trauma Patients
Project Team: The University of Texas Health Science Center at Houston; Athersys, Inc.; Memorial Hermann Hospital, Red Duke Trauma Institute
Award Amount: $1,999,802 (with additional cost share of $1,499,659)
Project Duration: 3 years
Project Objectives: The objective of this clinical study is to evaluate the safety and efficacy of MultiStem for the treatment of severely injured trauma patients suffering hemorrhagic shock for the prevention and early treatment of inflammatory complications. The project team hypothesizes that infusing MultiStem early after injury will provide therapeutic benefit to the multiply-injured, post-hemorrhagic shock trauma patients by decreasing the incidence of acute kidney injury (AKI).
Year One Accomplishments:
- Initiated steps to prepare for a pre-Investigational New Drug (IND) application filing and meeting with the U.S. Food and Drug Administration (FDA)
- Requested and scheduled a Type A meeting with the FDA regarding an IND application
- Initiated planning for the clinical trial, including:
a. Completion of the Investigator’s Brochure/Case Report Forms
b. Logistical management in conjunction with Athersys, Inc. for cell production and distribution for the clinical trial
c. Executed agreements with external collaborators