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Strain-Programmed Bioadhesive Patch for Enhanced Diabetic Wound Healing

用于增强糖尿病伤口愈合的应变程序生物粘附贴片

基本信息

批准号：
10818916
负责人：
Hyunwoo Yuk
金额：
$ 110.54万
依托单位：
SANAHEAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-07 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10818916
关键词：
Acceleration Address Adhesives African American population Aftercare Aging Amputation Biocompatible Materials Biological Products Chronic Clinical Clinical Trials Cutaneous Development Devices Diabetes Mellitus Diabetic Foot Ulcer Diabetic mouse Economic Burden Ensure Epithelium FDA approved Face Family suidae Frequencies Future Growth Factor Guidelines Healthcare Systems Hispanic Populations Human Impaired wound healing Industry Intervention Light Low income Lower Extremity Mechanics Modeling Outcome Patients Performance Pharmaceutical Preparations Phase Platelet-Derived Growth Factor Pre-Clinical Model Preparation Prevalence Quality of life Recombinant Growth Factor Reporting Risk Shapes Skin Skin graft Small Business Innovation Research Grant Societies Technology Testing Therapeutic Tissue Adhesives Treatment Cost Treatment Efficacy Ulcer Underserved Population United States Validation Veterans Work aging population biomaterial compatibility burn wound chronic wound clinical trial protocol clinical trial readiness commercialization cost db/db mouse design diabetic diabetic ulcer diabetic wound healing economic cost healing humanized mouse in vivo manufacture mechanical properties meetings mouse model porcine model pre-clinical preclinical evaluation preclinical study prototype regenerative scaffold skin wound treatment optimization wound wound closure wound healing

项目摘要

ABSTRACT The objective of this proposal is to optimize and validate the strain-programmed bioadhesive patch in compliance with FDA regulatory guidance for the FDA IDE approval in advance of the future pivotal clinical trial and ultimate regulatory clearance and commercialization. In light of the huge and rapidly growing clinical and economic costs of chronic diabetic wounds and associated complications, various treatments including skin scaffolds and growth- factor-based drugs have been proposed and clinically tested. To date, however, the existing approaches still face several limitations for diabetic wound healing including limited therapeutic efficacy and/or high cost of product/treatment. To address these limitations of existing solutions, during the prior development (Phase I- equivalent), our collaborative team developed a proof-of-concept prototype of a strain-programmed bioadhesive patch for enhanced diabetic wound healing by uniquely utilizing pro-regenerative mechanical modulation. The preliminary pre-clinical validation and analysis based on in vivo db/db mice, diabetic porcine, and diabetic humanized mice models revealed the promising therapeutic potential and underlying mechanisms of the strain- programmed bioadhesive patch for the accelerated healing of diabetic cutaneous wounds. Building upon the promising outcome of the prior development, under the scope of this Direct Phase II SBIR proposal, we will further optimize and validate the strain-programmed bioadhesive patch in compliance with relevant FDA regulatory guidance for the effective and broadly affordable treatment of chronic diabetic wounds such as DFU. If successful, the proposed project will allow SanaHeal to prepare and submit the FDA IDE package in advance to a pivotal clinical trial and ultimate commercialization with far-reaching benefits for patients and the healthcare system.

抽象的该提案的目的是优化和验证应变编程生物粘附贴片的合规性在未来关键临床试验和最终临床试验之前获得 FDA IDE 批准的 FDA 监管指导监管许可和商业化。鉴于巨大且快速增长的临床和经济成本慢性糖尿病伤口和相关并发症的各种治疗方法，包括皮肤支架和生长- 基于因子的药物已被提出并进行了临床测试。但迄今为止，现有的方法仍然糖尿病伤口愈合面临一些限制，包括有限的治疗效果和/或高昂的治疗成本产品/治疗。为了解决现有解决方案的这些局限性，在之前的开发过程中（第一阶段- 等效），我们的协作团队开发了应变编程生物粘合剂的概念验证原型通过独特地利用促再生机械调节来增强糖尿病伤口愈合的贴片。这基于体内 db/db 小鼠、糖尿病猪和糖尿病小鼠的初步临床前验证和分析人源化小鼠模型揭示了该菌株的有前途的治疗潜力和潜在机制用于加速糖尿病皮肤伤口愈合的程序化生物粘附贴片。建立在先前开发的有希望的成果，在直接第二阶段 SBIR 提案的范围内，我们将进一步优化和验证应变编程生物粘附贴片符合 FDA 相关规定针对 DFU 等慢性糖尿病伤口的有效且广泛负担得起的治疗的监管指南。如果成功，拟议的项目将允许 SanaHeal 提前准备并提交 FDA IDE 包进行关键的临床试验和最终商业化，为患者和医疗保健带来深远的利益系统。