PHMB-Impregnated Acellular Biologic Grafts for Treatment of Third-Degree Burns

PHMB 浸渍的脱细胞生物移植物用于治疗三度烧伤

基本信息

批准号：
10761354
负责人：
Nicholas Pashos
金额：
$ 87.42万
依托单位：
BIOAESTHETICS CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-01-18 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10761354
关键词：
Address Affect Age American Animal Model Animals Anti-Infective Agents Antibiotic Resistance Antibiotics Antigens Autologous Transplantation Biological Burn injury Cause of Death Cells Cessation of life Cicatrix Clinical Collagen Colony-forming units Complication Dermal Drug Delivery Systems Elastin Engraftment Extracellular Matrix Failure Family suidae Female Fibroblasts Fibroins Goals Good Manufacturing Process Hospitalization Human Hydrogels Hypertrophic Cicatrix Immune Infection Infection Control Infection prevention Legal patent Length of Stay Liquid substance Local Anti-Infective Agents Mammalian Cell Measurement Mechanics Mediating Medical Medical Care Costs Medical Device Mental Health Methods Microcirculation Modeling Necrosis Oral Administration Patient-Focused Outcomes Patients Performance Pharmaceutical Preparations Phase Polymers Porosity Preclinical Testing Process Proteins Pseudomonas aeruginosa Risk Risk Reduction Silk Site Skin Skin graft Specific qualifier value Sterility Sterilization Surgical incisions System Techniques Testing Therapeutic Agents Tissue Donors Tissue Grafts Tissues Toxic effect Wound Infection base biomaterial compatibility burn model burn wound crosslink drug release profile efficacy evaluation falls gamma irradiation healing health related quality of life improved improved outcome in vivo infection risk innovation male manufacture mechanical properties minimal risk mortality novel novel strategies pathogen phase 1 study physical conditioning polyhexamethylene biguanide porcine model product development reconstruction regenerative research and development scaffold severe burns sex skin burn standard of care third degree burn tissue regeneration wound wound bed wound closure wound healing

项目摘要

SUMMARY To improve patient outcomes, BioAesthetics is developing a drug-eluting acellular dermal graft for single-stage reconstruction of full-thickness burns. Nearly half a million Americans are affected each year by burns requiring medical treatment, with nearly 40,000 patients needing to be hospitalized. The annual medical cost of burns is $1.5 billion. Burn wounds have a long- lasting impact on health-related quality of life and affect both physical and mental health. Infections are the most frequent wound healing complication, with up to a third of patients with burns developing infections, and are the leading cause of death. Our innovation lies in creating a transformative acellular biologic graft (ABG) that enables sustained, local release of therapeutic agents at the burn site. Our novel approach simultaneously provides a native dermal scaffold for patient-mediated tissue regeneration, while countering the onset of complications due to infection during the course of wound healing. Donor tissue processed with BioAesthetics’ patent-pending method to remove cells and immunogens (i.e., ABGs) have been show to support host-mediated tissue recellularization. To create ABGs that enable therapeutic agent release, BioAesthetics has developed a patent-pending polymer impregnation technique that generates hydrogel-based drug delivery systems within ABGs. In our Phase I project, BioAesthetics assessed the feasibility of this innovative product for treating third-degree burns and demonstrated that the ABGs are efficacious in porcine third-degree burn wound healing and infection barrier models. In this Phase II project, we propose further product development, related to clinical manufacturing of the graft, including evaluating donor tissue variability and terminal sterilization effects, and expansion of the preclinical testing to include porcine third-degree burn infected and uninfected wound healing and barrier function models. Following completion of these studies, the product will be poised for FDA regulatory filings. Ultimately, our goal is to improve clinical outcomes for patients by reducing complications that arise from burn wounds.

概括为了改善患者的结局，生物敏化剂正在开发一种用于洗脱药物的细胞皮肤移植物全厚度燃烧的单阶段重建。每年将近一百万美国人受到需要治疗的烧伤的影响，近40,000 需要住院的患者。烧伤的年度医疗费用为15亿美元。烧伤的伤口长对与健康相关的生活质量的持久影响并影响身心健康。感染最多经常伤口愈合并发症，多达三分之一的烧伤患者发育感染，是死亡的主要原因。我们的创新在于创建一个变革性的细胞生物移植（ABG）烧伤部位的治疗剂。我们的新颖方法只是为本地皮肤脚手架提供患者介导的组织再生，同时应对因感染而引起的并发症的发作失去治愈的过程。用生物作用的供体组织处理的专利方法可以去除细胞已经表明了免疫原（即ABG）支持宿主介导的组织卷积。创建ABG 这种使治疗剂释放的释放，Bioaesthetics开发了一种申请专利的聚合物浸渍在ABG中生成基于水凝胶的药物输送系统的技术。在我们的I阶段项目中，生物学评估了这种创新产品治疗三级的可行性烧伤并证明ABG在猪三级烧伤伤口愈合和感染中有效屏障模型。在此II阶段项目中，我们提出了与临床制造有关的进一步的产品开发移植物，包括评估供体组织变异性和末端灭菌作用，以及扩展临床前测试，包括猪三级烧伤感染和未感染的伤口愈合和屏障功能型号。完成这些研究后，该产品将被毒害用于FDA调节文件。最终，我们的目标是通过减少烧伤伤口引起的并发症来改善患者的临床结果。