Cell Sprayer for Chronic Wound Therapy

用于慢性伤口治疗的细胞喷雾器

基本信息

批准号：
7611097
负责人：
Adam J Katz
金额：
$ 9.96万
依托单位：
PLUROGEN THERAPEUTICS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-09-28 至 2011-02-28
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7611097
关键词：
3-Dimensional Accounting Address Adhesions Adipose tissue Adjuvant Therapy Adult Adverse effects Air American Amputation Animal Model Area Autologous Beds Biological Biology Biomedical Engineering Blood Vessels Businesses Caliber Caring Cell Therapy Cells Child Chitosan Chronic Chronic Care Clinical Clinical Trials Control Animal Coupling Culture Media Data Debridement Development Device Designs Devices Diabetes Mellitus Diabetic mouse Diabetic wound Dimensions Disease Doctor of Medicine Economic Burden Exhibits Fatty acid glycerol esters Fibroblasts Foundations Funding Generations Goals Growth Factor Guidelines Harvest Healed Health Human Immune Impaired wound healing In Vitro Individual Inflammation Injury Legal patent Life Marketing Medical Device Mentors Methods Modeling Morbidity - disease rate Mus Patients Phase Plastics Pluronics Population Pre-Clinical Model Procedures Process Quality of life Reconstructive Surgical Procedures Research Personnel Role Safety Science Serum Serum-Free Culture Media Shapes Skin Small Business Technology Transfer Research Solutions Sterile coverings Suction Lipectomy Surface System Technology Testing Therapeutic Thick Time Tissues Topical agent Translating Treatment Efficacy United States Universities Virginia Work Wound Healing aerosolized aging population base burn therapy cell type commercialization cost cost effectiveness db/db mouse design diabetic diabetic patient diabetic wound healing engineering design experience healing health economics human stem cells in vitro testing in vivo leptin receptor meetings non-diabetic novel open wound pre-clinical preclinical study pressure public health relevance regenerative tissue regeneration treatment strategy tumorigenesis wound

项目摘要

DESCRIPTION (provided by applicant): Chronic wounds, such as diabetic wounds, are a major global health and economic burden. In the United States alone, 10.8 million chronic wounds occur every year (de Zoysa et al., 2005) which is estimated to cost over $15 billion annually in the U.S. (Farley, 2005). Currently, the diabetes population in the United States is 20.8 million adults and children (American Diabetes Association), and at any given time, approximately 6% or 1.2 million diabetic patients have a chronic wound (de Zoysa et al., 2005). These wounds are typically characterized as very difficult to heal and may result in amputation. In the recent past, various biological wound therapies ("advanced wound therapeutics") have become available to the clinician. However, from a clinical standpoint, these products have not been universally embraced--mechanisms are not clearly understood, efficacy not always predictable or reproducible, and treatment guidelines are undefined. A collaborative team of investigators from the University of Virginia and Plurogen Therapeutics, Inc is developing a transformative cell-based therapy for healing chronic diabetic wounds. The new therapy, termed CEAL therapy, is based on the use of autologous human stem cells harvested during liposuction procedures (hASCs), which are formulated into self-adherent 3-dimensional multi-cell aggregates (SNiMs). CEAL therapy has proven both safe and effective in drastically accelerating the healing of diabetic wounds in a pre-clinical model. The next step toward commercialization of this novel wound healing therapy is testing in patients, but before this can be accomplished, a controlled method for delivering CEAL therapy must be developed and tested for feasibility. To this end, we propose the following specific aims in Phase I of STTR funding: Aim 1) Perform in vitro feasibilty tests of a 1st Generation CEAL Sprayer and optimize/re-design the device to meet eight well-defined engineering design specifications, and Aim 2) Perform in vivo feasibility tests of the CEAL Sprayer in a mouse model of diabetes-induced delayed wound healing. hASCs have a number of attributes that make them an appealing and unique therapeutic strategy for tissue regeneration and healing of chronic wounds, and CEAL therapy offers significant potential advantages related to cost-efficient commercialization, therapeutic efficacy, and end-user appeal. The proposed work will significantly advance this promising new therapy for a global health problem toward clinical use. PUBLIC HEALTH RELEVANCE: Chronic diabetic wounds are widespread among the global and aging population, and current treatments are inadequate. We have developed a novel cell-based therapy that utilizes a patient's own adipose (fat) tissue that demonstrates safety and efficacy in a pre-clinical small animal model of diabetic skin wounds. The goal of the proposed work is to develop a medical device/system that effectively and efficiently delivers adipose- derived cells to open wounds using an aerosolized spray-on mechanism.

描述（由申请人提供）：慢性伤口，例如糖尿病伤口，是全球主要的健康和经济负担。仅在美国，每年就会发生1,180万例慢性伤口（De Zoysa等，2005），估计在美国，每年的耗资每年耗资超过150亿美元（Farley，2005年）。目前，美国的糖尿病人群为2080万成人和儿童（美国糖尿病协会），在任何给定时间，大约6％或120万糖尿病患者患有慢性伤口（De Zoysa等，2005）。这些伤口通常被认为很难治愈，可能导致截肢。最近，临床医生可以使用各种生物伤口疗法（“晚期伤口疗法”）。但是，从临床的角度来看，这些产品尚未普遍接受 - 机构尚未清楚地理解，功效并不总是可预测或可再现的，并且治疗指南不确定。来自弗吉尼亚大学和Plurogen Therapeutics，Inc的研究人员的合作团队正在开发一种基于转化的细胞疗法，用于治愈慢性糖尿病伤口。这种称为CEAL疗法的新疗法基于在吸脂手术过程中收获的自体干细胞（HASC），该干细胞被配合为自粘合剂3维多细胞聚集体（SNIMS）。 CEAL疗法已证明在临床前模型中可以大大加速糖尿病伤口的愈合。这种新型伤口愈合疗法的商业化的下一步是在患者中进行测试，但是在完成此事之前，必须开发出一种用于提供CEAL疗法的控制方法，并测试可行性。为此，我们在STTR资金的第一阶段提出了以下特定目标：AIM 1）对第一代CEAL喷雾器进行体外的轻度测试，并优化/重新设计设备，以满足八个定义明确的工程设计规格，以及目标2）在糖尿病引起的延迟伤口愈合的小鼠模型中对CEAL喷雾器进行体内可行性测试。 HASC具有许多属性，使它们成为组织再生和慢性伤口愈合的吸引人和独特的治疗策略，CEAL疗法具有与具有成本效益的商业化，治疗功效和最终用户吸引力有关的重要潜在优势。拟议的工作将大大推动这种有希望的新疗法，用于临床使用。公共卫生相关性：慢性糖尿病伤口在全球和老龄化的人口中普遍存在，目前的治疗不足。我们已经开发了一种新型的基于细胞的疗法，该治疗利用患者自身的脂肪（脂肪）组织，该组织在糖尿病皮肤伤口的临床前小动物模型中表现出安全性和功效。拟议工作的目的是开发一种医疗设备/系统，该医疗设备/系统有效，有效地将脂肪衍生的细胞提供使用雾化的喷雾机制来打开伤口。