Approximately 75% of traumatic deaths occur during the first 3 days after injury, and are primarily due to uncontrolled hemorrhage and traumatic brain injury (TBI). After 3 days, the remaining 25% of 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 include acute kidney injury (AKI), acute respiratory distress syndrome (ARDS), venous thromboembolic disease (VTE), and 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 evacuation to damage control and definitive surgical treatment may prove impossible in future combat theaters. As a result, the military requires therapies which can mitigate the potential impacts of severe injuries and delays to surgical interventions in order to prevent mortality from combat wounds. Therefore, MTEC is seeking to support 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 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: 48 months
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. We hypothesize that infusing MultiStemearly after injury will provide therapeutic benefit to the multiply injured, posthemorrhagic 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:
- Completion of the Investigator’s Brochure/Case Report Forms
- Logistical management in conjunction with Athersys, Inc. for cell production and distribution for the clinical trial
- Executed agreements with external collaborators