A flowable microporous biomaterial as a low cost, high efficacy diabetic chronic ulcer treatment

一种可流动的微孔生物材料作为低成本、高效的糖尿病慢性溃疡治疗

基本信息

批准号：
9141912
负责人：
Westbrook M Weaver
金额：
$ 22.5万
依托单位：
TEMPO THERAPEUTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-16 至 2017-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9141912
关键词：
Acceleration Acute Address Adoption Allografting Amino Acid Substitution Amputation Animals Antibiotic Therapy Bandage Beds Biocompatible Materials Biomedical Engineering Blood Vessels Caring Characteristics Chronic Chronic Phase Cicatrix Clinic Crosslinker Data Debridement Dermal Development Diabetic Foot Ulcer Diabetic mouse Diabetic wound Emollients Engineering Exposure to Family suidae Fibroblasts Fibrosis Foundations Gel Gelatinase A Healed Healthcare Hematoxylin and Eosin Staining Method Human Hydrogels Impaired wound healing Infection Inflammation Injectable Injury Intervention Light Marketing Matrix Metalloproteinases Mechanics Medical Methods Modeling Monitor Morbidity - disease rate Mus Natural regeneration Nature Outpatients Pathway interactions Patient-Focused Outcomes Patients Phase Polyethylene Glycols Property Publishing Recurrence Shapes Site Skin Substitutes Splint Device Staging Sterile coverings Structure Surgical sutures System Technology Tensile Strength Therapeutic Tissue Grafts Tissues Translating Treatment Cost Trichrome stain Ulcer Vascularization Visit Work Wound Healing chronic wound cost db/db mouse diabetic diabetic patient diabetic wound healing ethylene glycol healing implantation improved improved outcome in vitro testing in vivo mortality mouse model particle phase 2 study pre-clinical public health relevance regenerative therapy research study safety study scaffold seal stem tissue regeneration wound

项目摘要

DESCRIPTION (provided by applicant): Chronic diabetic foot ulcers are a significant worldwide healthcare burden, reaching a cost of $11 billion in the US alone during 2014. These wounds are notoriously difficult to manage because of slow healing, weak tissue after healing, and high infection rates. Low-cost bandaging and wound dressings are used to treat diabetic wounds in the early stages, but have poor efficacy and often allow progression to the chronic phase, where expensive bioengineered skin substitutes are used. These bioengineered treatments have not shown sufficient efficacy to warrant reimbursement early at their high cost, and thus see low practical efficacy in wound care clinics today. In 2014 there were 100,000+ amputations performed due to diabetic foot ulcers, and the average cost of an outpatient visit was $4500 with ulcer healing rates of only 50%, and recurrence rates above 30%. It is clear that a significant market opportunity exists to create a biomaterial therapy with the efficacy of an advanced skin substitute at the cost of a wound dressing. Low product cost and ease-of-use will drive reimbursement and adoption in the early (acute) phase of wound care, and a regenerative therapy will increase healed tissue mechanical and vascular properties mitigating the chronic wound phase, improving outcomes for patients and reducing costs to payers. Until now, there have been no low cost treatments that when applied can integrate into the wound bed and promote regeneration without sutures or implantation. We at Tempo Therapeutics have developed a fundamentally new synthetic (low cost) poly(ethylene glycol) biomaterial (MAP gel) that is flowable (ease of application) and bonds to the wound bed upon application to produce a material that enables functional tissue regeneration. Our technology is the first of its kind, allowing filling of any shape/size wound bed with a synthetic, low cost product that actually promotes accelerated wound healing and functional tissue regeneration. Upon application within the wound bed, the material is set and bonded to the tissue bed with 30 seconds of white light exposure. This unique approach provides a microporous network of void space in the material where tissue can freely grow into the material before it is degraded. In vivo, the MAP gel enables immediate wound sealing, accelerated healing, and increased regeneration with a single application to the wound taking only minutes. Here we aim to continue the development of the MAP gel for the treatment of slow-healing diabetic wounds. Specifically, we will engineer a slowly degrading material to address slow healing wounds, and harness the modular nature of our material to create degradation profiles that will support large tissue structure formation in vivo (a characteristic unique to the MAP gel and previously unobtainable with current technologies). We will assess both the rate of tissue healing and the amount of tissue regeneration in a diabetic murine wound healing model, as well as the mechanical strength of the reformed tissue after healing compared to current treatments. Completion of our proposed Aims will result lay the groundwork for successful phase II large animal porcine studies of safety and efficacy, ultimately towards a strong FDA portfolio for 510(k) approval.

描述（由申请人提供）：慢性糖尿病足溃疡是全球范围内的一个重大医疗负担，2014 年仅在美国就造成了 110 亿美元的费用。这些伤口由于愈合缓慢、愈合后组织薄弱以及成本高而难以处理，这是出了名的。早期阶段使用低成本的绷带和伤口敷料来治疗糖尿病伤口，但效果不佳，并且通常会进展到使用昂贵的生物工程皮肤替代品的慢性阶段。生物工程治疗方法尚未显示出足够的疗效，无法以高昂的成本尽早获得报销，因此目前伤口护理诊所的实际疗效较低。2014 年，有超过 100,000 例患者因糖尿病足溃疡而进行了截肢手术，门诊的平均费用也很高。成本为 4500 美元，溃疡愈合率仅为 50%，复发率超过 30% 显然，创造一种具有先进功效的生物材料疗法存在巨大的市场机会。以伤口敷料为代价的皮肤替代品将推动伤口护理早期（急性）阶段的报销和采用，而再生疗法将增加愈合组织的机械和血管特性，从而减轻慢性损伤。到目前为止，还没有一种低成本的治疗方法可以融入伤口床并无需缝合或植入即可促进再生。（低的成本）聚（乙二醇）生物材料（MAP 凝胶）是可流动的（易于使用），并在使用后粘合到创面床上，生产出一种能够实现功能性组织再生的材料，我们的技术是同类技术中的首创。具有合成、低成本产品的任何形状/尺寸的伤口床，实际上促进加速伤口愈合和功能性组织再生。在伤口床内应用后，该材料在 30 秒的白光照射下凝固并粘合到组织床。独特的方法提供了微孔网络材料中的空隙空间，组织可以在材料降解之前自由生长到材料中。在体内，MAP 凝胶只需几分钟即可立即密封伤口，加速愈合并增加再生。继续开发用于治疗缓慢愈合的糖尿病伤口的 MAP 凝胶，具体来说，我们将设计一种缓慢降解的材料来解决缓慢愈合的伤口，并利用我们材料的模块化特性来创建支持大型组织结构的降解曲线。体内形成（一种独特的特征我们将评估糖尿病小鼠伤口愈合模型中的组织愈合速度和组织再生量，以及与当前技术相比愈合后重组组织的机械强度。完成我们提出的目标将为成功进行 II 期大型动物猪的安全性和有效性研究奠定基础，最终为 FDA 的 510(k) 批准提供强大的产品组合。