Chronic wounds, such as diabetic wounds, are a major global health and economic burden. In the United States alone, 10.8 million chronic wounds occur every year (de Zoysa et al., 2005) which is estimated to cost over $15 billion annually in the U.S. (Farley, 2005). Currently, the diabetes population in the United States is 20.8 million adults and children (American Diabetes Association), and at any given time, approximately 6% or 1.2 million diabetic patients have a chronic wound (de Zoysa et al., 2005). These wounds are typically characterized as very difficult to heal and may result in amputation. In the recent past, various biological wound therapies (""""""""advanced wound therapeutics"""""""") have become available to the clinician. However, from a clinical standpoint, these products have not been universally embraced--mechanisms are not clearly understood, efficacy not always predictable or reproducible, and treatment guidelines are undefined. A collaborative team of investigators from the University of Virginia and Plurogen Therapeutics, Inc is developing a transformative cell-based therapy for healing chronic diabetic wounds. The new therapy, termed CEAL therapy, is based on the use of autologous human stem cells harvested during liposuction procedures (hASCs), which are formulated into self-adherent 3-dimensional multi-cell aggregates (SNiMs). CEAL therapy has proven both safe and effective in drastically accelerating the healing of diabetic wounds in a pre-clinical model. The next step toward commercialization of this novel wound healing therapy is testing in patients, but before this can be accomplished, a controlled method for delivering CEAL therapy must be developed and tested for feasibility. To this end, we propose the following specific aims in Phase I of STTR funding:
Aim 1) Perform in vitro feasibilty tests of a 1st Generation CEAL Sprayer and optimize/re-design the device to meet eight well-defined engineering design specifications, and Aim 2) Perform in vivo feasibility tests of the CEAL Sprayer in a mouse model of diabetes-induced delayed wound healing. hASCs have a number of attributes that make them an appealing and unique therapeutic strategy for tissue regeneration and healing of chronic wounds, and CEAL therapy offers significant potential advantages related to cost-efficient commercialization, therapeutic efficacy, and end-user appeal. The proposed work will significantly advance this promising new therapy for a global health problem toward clinical use.
Chronic diabetic wounds are widespread among the global and aging population, and current treatments are inadequate. We have developed a novel cell-based therapy that utilizes a patient's own adipose (fat) tissue that demonstrates safety and efficacy in a pre-clinical small animal model of diabetic skin wounds. The goal of the proposed work is to develop a medical device/system that effectively and efficiently delivers adipose- derived cells to open wounds using an aerosolized spray-on mechanism.
