Clinical Evaluation of StrataGraft Skin Tissue

描述(申请人提供)：严重烧伤和皮肤的其他主要创伤是危及生命的伤害，通常需要立即手术治疗。通常，这包括用身体皮肤或合成敷料暂时覆盖伤口，以防止感染和脱水。伤口的永久闭合通常是在伤口愈合到可以接受自体移植组织的程度后，通过自体中厚皮肤移植来完成的。虽然这种方案是严重皮肤创伤的标准护理方案，但身体皮肤的可获得性有限，来自供体组织的病原体传播的可能性，以及身体皮肤的最终排斥反应，给这种方法带来了严重的缺点。需要使用安全和有效的身体皮肤替代品来改善这些危及生命的伤口患者的护理。 Stratech公司开发了一种新型的培养皮肤替代组织--StrataGraft(Tm)皮肤组织，用于自体移植前严重皮肤伤口的临时治疗。StrataGraft(Tm)组织的开发和优化部分由这项SBIR项目的第一阶段提供资金。StrataGraft(Tm)组织是一种活的组合皮肤替代品，具有完全分层的表皮层，具有与天然表皮相当的渗透屏障功能。美国食品和药物管理局已经批准了Stratech的一项I/II期临床试验(IND#10113)，以评估StrataGraft(TM)皮肤组织作为身体皮肤替代品在临时处理需要手术干预的严重皮肤缺陷方面的安全性和有效性。这项第二阶段的SBIR建议旨在通过对StrataGraft(Tm)皮肤组织进行临床评估，在第一阶段项目成功的基础上再接再厉。成功完成这一L/11期临床试验将使Stratech能够进行关键的III期临床试验，从而使StrataGraft(Tm)皮肤组织最终实现商业化，作为一种治疗烧伤和其他严重皮肤创伤的改进疗法。

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.