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

• 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
• 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

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.

摘要 为了改善患者的预后，生物美学公司正在开发一种药物洗脱的脱细胞真皮移植物，用于 全层烧伤的单期重建。 每年有近50万美国人受到烧伤的影响，需要接受治疗的人数接近4万 需要住院治疗的病人。烧伤每年的医疗费用为15亿美元。烧伤的伤口有很长的- 对与健康有关的生活质量产生持久影响，并影响身心健康。感染最多的是 频繁的创面愈合并发症，多达三分之一的烧伤患者发生感染，并且是 头号死因。 我们的创新在于创造了一种变革性的脱细胞生物移植物(ABG)，使其能够持续、局部释放 烧伤现场的治疗剂。我们的新方法同时提供了一种天然的真皮支架 患者介导的组织再生，同时对抗因感染而在治疗期间出现的并发症 伤口愈合的过程。用BioAestics正在申请专利的方法处理供体组织以去除细胞 免疫原(即ABGs)已被证明支持宿主介导的组织再细胞化。创建ABG的步骤 生物美学公司开发了一种正在申请专利的聚合物浸渍技术，使治疗剂能够释放 在ABGs中产生水凝胶给药系统的技术。 在我们的第一阶段项目中，生物美学公司评估了这一创新产品用于治疗三度角的可行性 烧伤和证明ABGs在猪三度烧伤创面愈合和感染方面是有效的 障碍模型。在这个第二阶段的项目中，我们建议进一步开发与临床制造相关的产品 包括评估供体组织的变异性和最终绝育效果，以及扩大 临床前测试包括猪三度烧伤感染和未感染的创面愈合和屏障功能 模特们。在这些研究完成后，该产品将提交FDA监管文件。最终， 我们的目标是通过减少烧伤创面引起的并发症来改善患者的临床结果。