SBIR Phase I: Improving the Healing of Problematic Skin Wounds with Topical Application of Growth Factors Derived from Choroid Plexus

这个小企业创新研究（SBIR）一期项目将专注于开发一种治疗性凝胶，该凝胶含有脉络膜丛（CP）分泌的天然生长因子的全部补充，用于主动伤口护理市场，包括有问题的浅表皮肤伤口，如糖尿病溃疡。高剂量的单一重组因子在治疗这些伤口方面显示出有限的价值，长期的副作用在累积暴露于毫克量后表现出来。CytoSolv开发的独特技术使用多种CP蛋白来引发协同“鸡尾酒”。减少累积暴露于任何一种蛋白质的效果，同时通过涉及多种再生途径增强药理学影响。这项研究的更广泛/商业影响扩展到组织再生，并且CytoSolv已经启动了治疗糖尿病溃疡的临床前开发。这些伤口是世界上大多数下肢截肢的原因，也是糖尿病患者住院的主要原因之一，占美国所有住院患者的25%。最近发展的生物疗法由于有效性证据不一致，尚未被临床广泛接受。因此，糖尿病溃疡并发症的管理问题仍然是我们医疗保健系统致残和成本的主要来源，仅在美国就有一个活跃的伤口护理市场，估计价值200亿美元，超过115家公司为570万患者提供产品。当前项目的目标是开发一种基于CP因子技术的廉价、有效的治疗方法。

This Small Business Innovation Research (SBIR) Phase I project will focus on the development of a therapeutic gel containing the full complement of naturally occurring growth factors secreted by the choroid plexus (CP) for use in the active wound care market, including problematic superficial skin wounds such as diabetic ulcers. High doses of single recombinant factors have shown limited value in treating these wounds, with long-term side effects manifesting after cumulative exposure to milligram quantities. The unique technology that CytoSolv has developed employs multiple CP proteins to elicit a synergistic ?cocktail? effect that reduces the cumulative exposure to any one protein, while enhancing the pharmacologic impact by involving multiple regenerative pathways.The broader/commercial impacts of this research extend to tissue regeneration, and CytoSolv has initiated preclinical development to treat diabetic ulcers. These wounds are responsible for the majority of lower extremity amputations in the world, and are among the principal reasons for hospitalization of diabetic patients, accounting for 25% of all admissions in the US. Recently developed biologic therapies have not been widely accepted clinically due to inconsistent evidence of useful efficacy. As a result, the problem of managing complications of diabetic ulcers remains a major source of disability and cost to our health care system, with an active wound care market estimated at $20 billion in the US alone, and more than 115 companies delivering products for 5.7M patients. The goal of the current project is to develop an inexpensive, efficacious therapy based on the CP factor technology.