Clinical Trial of Antimicrobial Skin to treat Diabetic Ulcers

抗菌皮肤治疗糖尿病溃疡的临床试验

基本信息

批准号：
8518300
负责人：
Allen R. Comer
金额：
$ 104.95万
依托单位：
STRATATECH CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-09-30 至 2016-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8518300
关键词：
20 year old Acinetobacter baumannii Address Advisory Committees Amputation Animal Model Animals Ankle Anti-Infective Agents Bacteria Basic Science Biological Burn injury CAP18 lipopolysaccharide-binding protein Cell Line Cell Therapy Cells Chronic Clinical Clinical Research Clinical Trials Complications of Diabetes Mellitus Contralateral Cyclic GMP Data Diabetes Mellitus Diabetic Foot Ulcer Diabetic ulcer Diagnosis Digestive System Disorders Exhibits Future Genetic Goals Growth Factor Healed Health Professional Heel Hospitalization Hospitals Host Defense Human Individual Infection Institutes Kidney Diseases Lead Leukocytes Life Limb structure Lower Extremity Methods Modeling Modification Morbidity - disease rate Multi-Drug Resistance Non-Viral Vector North America Numbness Pathology Peptides Phase Property Published Comment Qualifying Quality Control Recombinant DNA Recommendation Reporting Safety Skin Skin Substitutes Skin Tissue Skin Ulcer Small Business Innovation Research Grant Source Stem cells Sterile coverings Survival Rate Testing Therapeutic Tissues Ulcer United States United States Food and Drug Administration Virus Voting Work Wound Healing Wound Infection angiogenesis antimicrobial cathelicidin cell bank design diabetic diabetic patient experience foot fungus healing improved innovation keratinocyte manufacturing process meetings microorganism mortality novel outcome forecast pathogen pre-clinical preclinical study progenitor repaired standard of care tool weapons wound

项目摘要

DESCRIPTION (provided by applicant): The goal of this Type 2 Competitive Renewal SBIR application to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct a phase I/II clinical trial to investigate the safety and early efficacy of a novel antimicrobial living human skin substitute for the treatment of a life-threatening complication of diabetes: chronic, nonhealing skin wounds. Infected, nonhealing skin wounds contribute significantly to morbidity and mortality in individuals with diabetes mellitus and are a major reason for hospitalization of people with diabetes. In the United States alone, each year there are 1.5 million new cases of diabetes diagnosed in people aged 20 years or older. Hospital discharge data indicate that up to 20% of all diabetics hospitalized in North America within a given year will experience nonhealing skin wounds usually localized on ankles, feet, and heels. Unfortunately, the number of hospital discharges in the United States for diabetes-related amputations has risen in the last decade and as of 2006, 82,000 diabetes-induced lower extremity amputations occur each year. For the diabetic patient, amputation of one limb is associated with a poor prognosis for the contralateral limb, and a decreased rate of survival in general. An alarming 85% of diabetes-related lower extremity amputations have an infected, chronic, nonhealing skin wound as a primary causal factor. To address the critical need for innovative therapeutic approaches for treatment of chronic nonhealing skin wounds, Stratatech Corporation has used the NIKS(R) cell line to generate an antimicrobial living human skin substitute. A unique property of the NIKS(R) cells is that they are a long-lived keratinocyte progenitor and consistent source of genetically uniform, non-tumorigenic, pathogen-free human cells. Because they are readily amenable to genetic modification through the use of non-viral vectors, the NIKS(R) keratinocytes are ideal for ex vivo genetic modification approaches to create human biological skin substitutes with enhanced antimicrobial capabilities. Stratatech strategically focused on the endogenous host defense peptide human cathelicidin (hCAP-18/LL-37) because it exhibits antimicrobial activity against a broad range of microorganisms, fungi, and viruses and is a critical component of innate defenses against wound infection.

描述（由申请人提供）：此类型2竞争性更新SBIR的目的是对国家糖尿病研究所，消化和肾脏疾病（NIDDK）进行I/II期临床试验，以调查新型抗菌活性人体皮肤替代疾病的安全性和早期疗效，以治疗生命中的疾病造成疾病的疾病，以置换生命的疾病造型。被感染的，非污染的皮肤伤口对糖尿病患者的发病率和死亡率显着贡献，这是糖尿病患者住院的主要原因。仅在美国，每年在20岁以上的患者中就有150万例诊断出的新糖尿病病例。医院出院数据表明，在给定的一年内，在北美住院的所有糖尿病患者中，多达20％的糖尿病患者通常会遇到通常位于脚踝，脚和高跟鞋上的非聊天皮肤伤口。不幸的是，在过去的十年中，美国与糖尿病相关截肢的住院数量增加了，截至2006年，每年发生了82,000个糖尿病引起的下肢截肢。对于糖尿病患者，一个肢体的截肢与对侧肢体的预后不良有关，总体上的生存率降低了。令人震惊的85％的与糖尿病相关的下肢截肢具有感染的，慢性，无污染的皮肤伤口，是主要因果因素。为了满足对慢性非污染皮肤伤口的创新治疗方法的关键需求，Stratatech Corporation使用NIKS（R）细胞系来产生一种抗菌素活着的人类皮肤替代品。 NIKS（R）细胞的独特特性是它们是长期寿命的角质形成细胞祖细胞，并且是遗传均匀，非肿瘤，无病原体的人类细胞的一致来源。由于它们很容易通过使用非病毒载体来适应遗传修饰，因此NIKS（R）角质形成细胞非常适合在体内遗传修饰方法中创建具有增强抗菌功能的人类生物皮肤替代品。 StrataTech从策略上关注内源性宿主防御肽人类cathelicidin（HCAP-18/LL-37），因为它表现出针对广泛的微生物，真菌和病毒的抗菌活性，并且是与伤口感染的先天防御率的关键组成部分。

项目成果

期刊论文数量（1）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Inhibition of multidrug-resistant Acinetobacter baumannii by nonviral expression of hCAP-18 in a bioengineered human skin tissue.

DOI：
10.1038/mt.2008.289
发表时间：
2009-03
期刊：
MOLECULAR THERAPY
影响因子：
12.4
作者：
Thomas-Virnig, Christina L.;Centanni, John M.;Johnston, Colette E.;He, Li-Ke;Schlosser, Sandy J.;Van Winkle, Kelly F.;Chen, Ruibing;Gibson, Angela L.;Szilagyi, Andrea;Li, Lingjun;Shankar, Ravi;Allen-Hoffmann, B. Lynn
通讯作者：
Allen-Hoffmann, B. Lynn