SBIR-STTR Award

Medicare data indicates that more than 8 million beneficiaries had a wound or wound-related infection impacting quality of life of seniors and estimated costs to the system of between $28.1B to $96.8B1 annually. Development of novel treatments to address chronic wounds is an identified priority for the National Institute of Aging. A unique FDA-registered regenerative product, an autologous homologous skin construct (AHSC) (SkinTE™, PolarityTE, Inc., Salt Lake City, UT) has shown promise for the treatment of chronic wounds including pressure ulcers, diabetic foot ulcers and lower extremity chronic wounds. Two open-label single arm pilot studies have demonstrated the efficacy of the AHSC in treating diabetic foot ulcers and venous leg ulcers (VLU)2,3,4. In these open-label trials, 91% of DFUs closed within 8 weeks and 80% of VLU’s had closed within 12 weeks of a single treatment. Currently, clinical use of the AHSC requires a two-step procedure, first taking a full-thickness skin harvest from the patient, which is shipped to PolarityTE MD’s biomanufacturing facility where it is used to manufacture the AHSC, which is then returned to the clinician for application into the wound. This two-step procedure creates challenges for patients in rural communities who must travel long distances to access health care and return for the second procedure. Additionally, the increasing closure of rural hospitals is reducing rural access to health care and puts more emphasis on outpatient office delivery of care. Furthermore, market research has indicated that providing the AHSC “on-demand” in the clinician’s office will increase the potential usage by 7%. In order to provide “on-demand” AHSC, we propose the development of a table-top, portable, point-of-care (POC) device that would allow the manufacturing of AHSC in the outpatient office, clinic, or remote hospital. Critical steps for AHSC processing include 1) washing of the skin harvest to reduce bioburden and 2) processing the tissue with the addition of biocompatible solutions in a manner to create the AHSC and impart certain desired characteristics, including certain handling characteristics. This proposal addresses the technical challenges of developing a fluid management system of the POC to ensure the manufacturing requirements for bioburden reduction and AHSC viscosity are achieved. Currently bioburden is reduced through a series of manual washing steps. SPECIFIC AIM 1 will design and test an automated washing system that meets or exceeds the bioburden reeducation requirements of the current manufacturing process. The system must be capable of exchanging large volumes of fluid across the skin harvest and then collect the fluid in a waste containment chamber. SPECIFIC AIM 2 will design and test a fluid management system that can assess AHSC viscosity and adjust biocompatible fluid levels used during processing to meet the viscosity requirements of the product to ensure optimal handling characteristics.

Public Health Relevance Statement:
PROJECT NARRATIVE The burden of chronic wounds on the elderly is immense both in prevalence1,2,3 and cost to the healthcare system, estimated at more than $10B annually4. A unique FDA-registered autologous homologous skin construct treatment for chronic and acute wounds is available as a 2-stage procedure.5,6,7 Rural and remote populations must often travel substantial distances to receive health care limiting their access, which is worsened by the increasing closure of rural hospitals. This proposal will facilitate the development of a portable point of care device that will allow a single stage treatment that can performed in an outpatient office eliminating current logistical requirements, making this treatment available to underserved populations.

Project Terms:
acute wound; Address; Affect; Age; American; Anatomy; arm; Autologous; Back; Bacteria; beneficiary; Biomanufacturing; biomaterial compatibility; care delivery; Cells; Characteristics; chronic wound; Cities; Clinic; Clinical; Containment; cost; cost estimate; Cutaneous; Data; decubitus ulcer; design; Development; Devices; Diabetic Foot; Diabetic Foot Ulcer; Disasters; Elderly; Elements; Ensure; Escherichia coli; Event; Feedback; Goals; Grant; Harvest; health care availability; Healthcare; Healthcare Systems; Hospitals; Hour; Housing; Human; Incidence; Individual; Infection; Island; Leg Ulcer; Liquid substance; Location; Logistics; Lower Extremity; Manuals; manufacturing process; Market Research; Measurement; Measures; mechanical behavior; Medicare; microbial; Military Personnel; National Institute on Aging; novel; open label; Outpatients; Patients; physical property; Pilot Projects; point of care; Point-of-Care Systems; Population; portability; Positioning Attribute; prevent; Procedures; Process; Provider; Quality of life; regenerative; remote location; Rotation; Rural; rural area; Rural Community; Rural Hospitals; Series; Ships; Site; Skin; Skin graft; Skin Tissue; Sodium Chloride; Specialist; Staphylococcus aureus; Sterility; Syringes; System; Techniques; Testing; Thick; tissue processing; Tissues; Travel; Underserved Population; Venous; Viscosity; wasting; wound; wound bed; wound closure; wound treatment