SBIR-STTR Award

Recombinant and autologous growth factor healants are being utilized increasingly for clinical and surgical wound healing scenarios. Recombinant growth factors are therapeutically applied to heal intractable diabetic and venous ulcers, while autologous growth factors are used in major orthopedic applications such as spinal fusion and joint implants. However, the cost and/or inconvenience of the current growth factor-based products have impeded their widespread use. The future of surgical growth factor healants will thus depend on the ease with which autologous growth factors can be obtained, and significant cost reduction. Recognizing this, the applicants have designed a process for quick, convenient and relatively inexpensive intraoperative harvesting of autologous platelets with preserved growth factors. The novel system described in this proposal obviates the need for centrifugation, and it can, for the first time, enable routine harvesting of autologous growth factors from small volumes of blood during surgery. The harvesting of platelets by this process can allow the delivery of growth factors using a wide variety of approved substrates such as hydrogels, collagen compositions, alginates etc. The eventual goal of this concept is to make autologous growth factors readily available for use in a wide variety of soft and hard tissue surgical applications. PROPOSED COMMERCIAL APPLICATION: The proposed project will lead to the development of a convenient, quick and inexpensive process to isolate autologous growth factors that can be delivered to augment wound healing in various soft and hard tissue surgical procedures.

Thesaurus Terms:
biotherapeutic agent, cell sorting, growth factor, platelet, sample collection, technology /technique development, wound healing centrifugation, cytotoxicity, drug design /synthesis /production, protein purification, surgery material /equipment human tissue

An emerging clinical approach for augmenting wound healing involves the use of recombinant or autologous growth factors for improved therapeutic outcomes in various surgical and outpatient situations. However, currently available growth factor-based wound healing therapies are relatively expensive and often cumbersome to use. The applicants have developed a simple and inexpensive technique obviates the need for cumbersome equipment. Phase I studies have demonstrated that high platelet yields with included growth factors can be obtained using a disposable device that allows controlled delivery of platelet growth factors with significant mitogenic activity resulting accelerated cell growth. In this Phase II study, the applicants proposes to undertake and complete pre-commercialization investigations of a convenient and inexpensive intraoperative process to harvest and concentrate platelets with contained growth factors from autologous for enhancing wound healing. Optimization and characterization of key parameters associated with obtaining platelet concentrates from autologous blood using the applicants' method will be conducted. A prototype device-kit that simplifies and automates the applicants' process will be developed and tested. The prototype will consist of a base unit and disposable components that will integrate and execute the Hemogenesis process in a simple, and automated fashion. The in-vivo wound healing activity of platelets retrieved by the applicants' technique will be tested in soft and hard tissue animal models. A procine skin wound model will be utilized to simulate soft-tissue wounds, and a porcine bone defect (by osteotomy) model will be used to simulate hard tissue wounds. The efficacy of autlogous platelet growth factors will be tested in these animal models using various carrier substrates such as alginate, fibrin, hydrogel, and chitosan-calcium phosphate sponge. These studies will be an important precursor to commercialization efforts and clinical investigations that will eventually test the efficacy of the autologous platelet growth factor product that is obtained by the Hemogenesis technique.

Thesaurus Terms:
biotherapeutic agent, cell sorting, growth factor, platelet, technology /technique development, tissue /cell preparation, wound healing centrifugation, cytotoxicity, drug design /synthesis /production, protein purification, surgery material /equipment clinical research, human tissue, swine