Commercial Scale Up of Bone Marrow-Derived Mesenchymal Stem Cells for Regenerative Medicine
Hemorrhage is the leading cause of trauma-related death in both civilian and military populations. A study of 4,596 battlefield fatalities from Operation Iraqi Freedom and Operation Enduring Freedom determined that hemorrhage accounted for 91% of potentially survivable fatalities occurring prior to arrival at a Medical Treatment Facility (Eastridge et al., 2012). Additionally, of those 888 deaths attributable to hemorrhage, 67% were from truncal hemorrhage (Eastridge et al., 2012). This supports the vital need for intervention in far forward military environments.
The primary deliverable of this project will be a prototype that can stop life threatening bleeding in the abdominal intracavitary region of patients who are delayed in receiving definitive surgical care. Ideally, a noncompressible hemorrhage control solution should:
- Be capable of minimizing and/or stopping life threatening noncompressible bleeding in the abdominal intracavitary region of the body without causing further damage
- Be more efficacious, operational and environmentally suitable and affordable than the current standard of care
- Be easily usable by combat medics, physician’s assistants, and/or physicians at Point of Injury Role 1 and during patient transport without additional equipment.
- Be bioabsorbable or easily removable without causing further damage (if applicable to the technology)
- Achieve clearance/approval by the U.S. Food and Drug Administration (FDA) for use in trauma patients
- Be a small form factor, which does not add any significant weight or cube to the medical personnel’s sets, kits or outfits
- Have a low logistical footprint (e.g., storage conditions, shelf life, rugged)
- Require no specialized maintenance personnel, maintenance requirements, or tools to employ or maintain the system
- Be used as intended in austere military operational environments (e.g., low visibility, extreme temperature variations, blackout conditions, ruggedness)
- Be capable of passing military testing requirements, including but not limited to, airworthiness, safe-to-fly testing and environmental testing as stated in the appropriate documents (for example, the current MIL STD 810 and Joint En route Care Equipment Test Standard (JECETS))
- Be capable of functioning in a prolonged field care setting in future Multi-Domain Operations (MDO) where evacuation is not guaranteed within one hour
- Be at a technology readiness level (TRL) of 5 or above [For definitions of TRLs: https://mtec-sc.org/wp-content/uploads/2016/12/TRL-definitions.pdf]
The research project award recipient was selected from the Offerors who responded to MTEC’s Request for Project Proposals (20-08-NCH).
Development of Vasobond as a Non-Compressible Hemorrhage Control Technology
Project Team: Medtrade Products
Award Amount: $1.22M (additional cost share = $93K)
Project Duration: 23 months
Project Objective: Medtrade proposes a prototype project to develop its commercial technologies to create a product designed for military medical use specifically to stop life threatening bleeding in the abdominal intracavitary region of patients who are delayed in receiving definitive surgical care. The proposed technology is an innovative, extreme performance resorbable hemostat based on a natural polysaccharide. It works by quickly absorbing blood/fluid, creating a robust gel like clot that is capable of bonding to the surrounding tissue, while attracting to the wound surface red blood cells and platelets to promote clot. This mode of action works independently of the body’s natural clotting cascade making it suitable for coagulopathic patients (trauma or drug induced). This proposal will describe the program of development for the technology (presented in two formats: granules in an applicator, and granule-impregnated gauze both of which are used throughout the US military Emergency services and Hospital for the control of major topical hemorrhaging ) to meet this goal. This proposed development program for the technology will allow the product to be used in pre hospital and hospital settings at the point of injury for serious life-threatening wounds including non-compressible hemorrhage. The resulting product will be able to stop bleeding within minutes without the requirement of compression, be carried easily by front-line personnel (medics, corpsman, etc.) to be used in an austere environment while awaiting transport to a surgical center. The product can be left in place indefinitely as it will reabsorb naturally, and will result in enhanced survivability and has the ability to be used successfully regardless of the coagulopathic condition of the patient.