Prototype Acceleration Awards

The Prototype Acceleration Award (PAA) mechanism focuses on advancing novel prototype technologies into the next major stage of development or next major milestone within a 12 month period of performance.  Examples of the next major stage of development/milestone include, but are not limited to:  late animal testing and regulatory filing; manufacturing; next clinical trial; regulatory approval; etc. Projects must eventually result in deliverables that transition medical solutions to government and/or industry partners. The research project award recipients were selected from the Offerors who responded to MTEC’s 17-02-Prototype Acceleration (PA) Request for Project Proposals (17-02-PA).

Pre-clinical assessment of bioprinted human skin for wound healing and skin regeneration

Project Team: Wake Forest University
Award Amount:  $299,999 (does not include proposed cost share of $150,000)
Project Duration: 12 Months
Project Objectives: The ultimate goal of a skin graft is to regenerate authentic anatomy and physiology of native skin. We have recently demonstrated bioprinting of skin constructs using human cells and matured them in vitro to stratified tri-layered structures containing epidermis, dermis and hypodermis, similar to native human skin. The overall goal of the project is to bioprint full-thickness human skin with hair follicle appendages, microvasculature, immune cells and pigmentation and use it as a skin graft in immunodeficient rats. The bioprinted skin graft will undergo extensive characterization of cell viability in vivo, cellular function, wound healing and skin regeneration. Long-term analyses will assess inflammatory cell infiltration, skin remodeling and potential fibrosis and integration with host tissues. Altogether, the study will constitute preclinical assessment of bioprinted skin graft for treatment of burn injuries and other skin-related injuries.

Young-Joon Seol Wake Forest Institute for Regenerative Medicine (WFIRM) demonstrates Bioprinting muscle tissue, Richard H. Dean Biomedical Building (A1).

Host-targeted Immune Stimulation by PUL-042 for Prevention of Pneumonia in a Ferret Model of the Damaged Lung

Project Team: Pulmotect, Inc., University of Alabama at Birmingham (Department of Pulmonary, Allergy, and Critical Care)
Award Amount: $300,000
Project Duration: 12 Months
Project Objective: PUL-042 is an innate immune stimulating therapeutic now in early clinical stage drug development. Administered by inhalation, PUL-042 activates defense mechanisms in the epithelial cells that line the lung, resulting in rapid protection from bacterial, viral, and fungal infections. Patients with smoke damaged lungs are especially vulnerable to developing pneumonia caused by infectious microbes, which increases mortality rates and the risks of long-term damage. The funded research study will evaluate the ability of PUL-042 to protect against infectious challenges in a chronic smoke damage model. If successful, PUL-042 could be further developed specifically for patients who have been exposed to smoke from fires and explosions.

Pneumonia Prevention in Ferret Model of Damaged Lung

Manufacturing of a Negative Pressure Wound Therapy Dressing for Hand Wounds: ReHeal Glove

Project Team: University of Texas at Arlington, ReHeal LLC
Award Amount: $227,487
Project Duration: 12 Months
Project Objective:  Complex hand wounds can be debilitating and current therapies often fail to restore hands to being adequate for daily living. Vacuum assisted wound closure is an effective method for healing hand injuries but this technique immobilizes the hand which is counterproductive for functional recovery. Our negative pressure wound dressing is an advanced hand wound care system that enables vacuum application while permitting motion during healing to preserve joint range of motion and dexterity. This wound care system is comprised of a flexible and transparent glove-shaped wound dressing which offers a better solution for hand wound care over current technologies. The goal of this project is to develop manufacturing processes and packaging for this wound dressing to enable future clinical trial.

Negative Pressure Wound Therapy

Natural Polymer Microbead and Electrospun Mesh Technologies for the Sustained Release of Regenerative Growth Factors for the Treatment of Burns and Ischemic Wounds

Project Team: SpherIngenics Inc. and Virginia Commonwealth University
Award Amount: $295,634 (cost share = $46,875)
Project Duration: 12 Months
Project Objective: The objective of this project is to develop and apply a sustained release delivery system for growth factors to promote healing and closure of chronic, ischemic wounds.  Specifically, alginate microbeads will serve as a sustained release delivery system for PLGA microparticles containing angiogenic growth factors VEGF and FGF-2 and will be applied to a challenging clinical model in both wildtype and diabetic rat models.  On the left is an image of the microbeads and microparticles once lyophilized for storage.  The center and right images show the microbeads containing PLGA loaded particles with a fluorescent protein once reconstituted in a physiologically balanced aqueous solution.  The system is lyophilizable allowing for a single step reconstitution in standard physiologic balanced solutions while still maintaining the spherical shape, release kinetics, and protein activity of the system prior to storage.  This greatly enhances shelf life of the product, ease of use and storage considerations.  Finally, the system is injectable through standard syringes and needles, thus alleviating the need for specialized injection, mixing, or curing equipment as is common with current growth factor delivery systems and hydrogels.

Polymer Microbead

Intelligently Engineered Skin for the Treatment of Severe Burns

Project Team: Upside Biotechnologies Ltd.
Award Amount: $300,000 (cost share = $970,000)
Project Duration: 12 Months
Project Objective: Upside Biotechnology aims to develop the treatment of choice for sufferers of large burns. Current treatment relies on repeated applications of split skin grafts; an approach which is slow and painful, requires long hospital stays, and often leads to poor cosmetic outcomes. For Upside’s product, an individual suffering from an acute major burn will have a single split skin graft or biopsy taken at the time the burn wound is initially debrided, typically shortly after admission. The skin sample will be sent to a central laboratory where the cells from the skin will be extracted and cultured using proprietary methods. For a typical major burn, it is expected that multiple full-thickness (epidermis and dermis) sheets of skin of 200 x 200 mm will be sent back from the central laboratory, ready to graft onto the patient’s burn after 16 days. The engineered skin is grown in a proprietary chamber on a specially designed, biodegradable, biocompatible mesh that confers excellent handling characteristics.

The objective of this MTEC project is to progress the development of the product to the point where it is ready to enter clinical trials. Specifically, the team will i) finalize development methods with appropriate validations and assays, ii)  set up GMP production facilities, and iii) prepare for a clinical trial including the completion of relevant documentation as well as obtaining ethics and regulatory authority approvals.

Engineered Skin
100x100mm sheet of engineered skin grown in Upside’s proprietary chamber grown on a frame (left) and after removal from the frame (right).