Clinical Evaluation of StrataGraft Skin Tissue

描述（由申请人提供）：严重烧伤和其他严重皮肤创伤是危及生命的损伤，通常需要立即手术干预。通常，这涉及用尸体皮肤或合成敷料临时覆盖伤口部位以防止感染和脱水。伤口的永久闭合通常是在伤口床愈合到它将接受自体移植组织的程度后，通过分层皮肤自体移植来实现的。尽管该方案是严重皮肤伤口的护理标准，但尸体皮肤的有限可用性、来自供体组织的病原体传播的可能性以及尸体皮肤的最终排斥对该方法造成了严重的缺点。需要使用尸体皮肤的安全有效的替代品，以改善对这些危及生命的伤口患者的护理。 Stratatech公司开发了一种新型的培养皮肤替代组织，StrataGraft（tm）皮肤组织，用于在自体移植之前临时处理严重的皮肤伤口。StrataGraft（TM）组织的开发和优化部分由SBIR项目的第一阶段部分资助。StrataGraft（TM）组织是一种具有完全分层的表皮层的活性组合皮肤替代物，其赋予与天然表皮相当的渗透屏障功能。FDA已经批准了Stratatech的I/II期临床试验（IND #10113），以评估StrataGraft（TM）皮肤组织作为尸体皮肤替代品在需要手术干预的严重皮肤缺损的临时管理中的安全性和有效性。本II期SBIR提案旨在通过对StrataGraft（tm）皮肤组织进行临床评价，以I期项目的成功为基础。该I/II期临床试验的成功完成将使Stratatech能够进行关键的III期临床试验，最终实现StrataGraft（TM）皮肤组织的商业化，作为烧伤和其他严重皮肤创伤管理的改进疗法。

DESCRIPTION (provided by applicant): Severe burns and other major trauma to the skin are life-threatening injuries that often require immediate surgical intervention. Typically, this involves temporary coverage of the wound site with cadaver skin or synthetic dressings to prevent infection and dehydration. Permanent closure of the wound is generally accomplished through split-thickness skin autografting after the wound bed has healed to the point that it will accept autograft tissue. Although this regimen is the standard of care for severe skin wounds, limited availability of cadaver skin, the potential for transmission of pathogens from donor tissue, and the ultimate rejection of the cadaver skin pose serious drawbacks to this approach. Safe and effective alternatives to the use of cadaver skin are needed to improve the care of patients with these life-threatening wounds. Stratatech Corporation has developed a novel cultured skin substitute tissue, StrataGraft(tm) skin tissue, for the temporary management of severe skin wounds prior to autografting. The development and optimization of StrataGraft(tm) tissue was funded in part by the Phase I portion of this SBIR project. StrataGraft(tm) tissue is a living combination skin substitute with a fully-stratified epidermal layer which imparts permeability barrier function comparable to that of native epidermis. The FDA has approved a Phase I/II clinical trial (IND#10113) for Stratatech to evaluate the safety and efficacy of StrataGraft(tm) skin tissue as an alternative to cadaver skin in the temporary management of severe skin defects requiring surgical intervention. This Phase II SBIR proposal is designed to build on the success of the Phase I project by performing a clinical evaluation of StrataGraft(tm) skin tissue. Successful completion of this Phase l/ll clinical trial will position Stratatech to conduct a pivotal Phase III clinical trial, leading to the ultimate commercialization of StrataGraft(tm) skin tissue as an improved therapy for the management of burns and other severe skin trauma.