Clinical Evaluation of StrataGraft Skin Tissue

StrataGraft 皮肤组织的临床评价

• 批准号: 6883632
• 负责人: Allen R. Comer
• 金额: $ 122.63万
• 依托单位: STRATATECH CORPORATION
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-06-01 至 2008-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6883632
• 关键词: artificial skin; biotechnology; burn therapy; clinical research; clinical trial phase I; clinical trial phase II; homologous transplantation; human subject; human therapy evaluation; patient oriented research; skin disorder; technology /technique development; tissue /cell culture; trauma; wound healing

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.

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伤害，通常需要立即进行手术干预。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创面愈合到可以接受自体移植组织的程度后，通过自体分层皮肤移植来实现的。尽管这种方案是严重皮肤伤口的护理标准，但尸体皮肤的可用性有限、供体组织传播病原体的可能性以及尸体皮肤的最终排斥对这种方法造成了严重的缺陷。需要安全有效的尸体皮肤替代品来改善对这些危及生命的伤口患者的护理。 Stratatech Corporation 开发了一种新型培养皮肤替代组织，即 StrataGraft(tm) 皮肤组织，用于在自体移植前临时处理严重皮肤伤口。 StrataGraft(tm) 组织的开发和优化部分由该 SBIR 项目第一阶段部分资助。 StrataGraft(tm) 组织是一种活体复合皮肤替代品，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。 FDA 已批准 Stratatech 进行 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临时管理需要手术干预的严重皮肤缺陷的安全性和有效性。该 II 期 SBIR 提案旨在通过对 StrataGraft(tm) 皮肤组织进行临床评估，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 能够开展关键的 III 期临床试验，从而最终实现 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。