HARVESTING AUTOLOGOUS PLATELETS FOR WOUND HEALING

收获自体血小板用于伤口愈合

基本信息

批准号：
7394872
负责人：
Don B Olsen
金额：
$ 98.7万
依托单位：
THROMBODYNE, INC.
依托单位国家：
美国
项目类别：
财政年份：
2001
资助国家：
美国
起止时间：
2001-08-15 至 2011-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7394872
关键词：
Abbreviations Acute Adenine Nucleotides Adenosine Agonist Alginates Animal Model Applications Grants Autologous Benign Biochemical Blood Blood Platelets Bone Regeneration Burn injury Cell Proliferation Cell Separation Cells Centrifugation Clinic Clinical Clinical Research Clinical Trials Clinical Trials Design Closure Collection Computer-Aided Design Connective Tissue Cutaneous Defect Development Devices EGF gene Environment Enzyme-Linked Immunosorbent Assay Epidermal Growth Factor Equipment Erythrocytes Family Fibroblast Growth Factor Filtration Funding Grant Growth Factor Harvest Healthcare Hydrogels Implantation procedure In Vitro Indium Label Lead Legal patent Marketing Maxillofacial Procedures Mediating Mediator of activation protein Medical Methods Modality Molds Operating Rooms Operative Surgical Procedures Orthopedics Outcome Outpatients Patients Phase Plasma Plastic Surgical Procedures Platelet-Derived Growth Factor Population Preclinical Testing Preparation Process Production Proteins Protocols documentation Randomized Controlled Clinical Trials Rate Recombinant Growth Factor Recombinants Recovery Research Risk Role Safety Sedimentation process Site Skin Skin graft Small Business Funding Mechanisms Small Business Innovation Research Grant Societies Sodium Chloride Solutions Specialist System Techniques Technology Therapeutic Therapeutic Uses Time Transforming Growth Factors Ulcer United States Food and Drug Administration Validation Varicose Ulcer Vascular Endothelial Growth Factors Venous Whole Blood Wound Healing base bone clinical efficacy clinically relevant comparative cost cost effective design desire ergonomics improved in vivo innovation inorganic phosphate interest novel programs prospective quality assurance sample fixation symposium wound

项目摘要

DESCRIPTION (provided by applicant): Improved understanding of the role of growth factors as biochemical mediators of wound healing has paved the way for a new family of bioactive therapeutic products to expedite wound healing. Delivery of growth factors (recombinant or as autologous platelets) has emerged as a possible commercial opportunity for improving the clinical outcomes of soft, bone, and connective tissue repair. However, wide acceptance of growth factors to accelerate wound healing has been hampered because current recombinant and autologous platelet growth factor-based products are prohibitively expensive and current methods for procurement of autologous platelets are cumbersome and time consuming. Moreover, none of the current platelet harvesting devices has FDA approved claims for wound healing. The applicants have developed a simple and inexpensive technique to rapidly obtain autologous platelet concentrate from blood (<10 min) without the need for expensive equipment. The process has been characterized and optimized to achieve high yields of platelets with normal growth factor content, and the safety and efficacy of the resulting platelet concentrate in accelerating cell proliferation in vitro and improved wound healing in animal models in vivo has been demonstrated. The objectives of this Phase II continuation application are to: (i) design and manufacture an automated device that is fully disposable to improve the robustness of platelet recovery and to further minimize operator involvement, and (ii) to establish clinical efficacy of the harvested platelet concentrate in promoting cutaneous wound healing. Product development activities will include computer aided design and manufacturing, rapid prototyping, molding, assembly, preclinical testing, and establishing a quality assurance program leading to Good Manufacturing Practices for limited production of the device. The clinical study will focus on treating acute skin wounds and venous ulcers with the obtained platelet concentrates using a protocol based on FDA guidance documents for wound healing studies. Results of this study using a convenient and affordable device could indicate, for the first time, the clinical utility of autologous platelet concentrates in accelerating cutaneous wound closure based on a prospective, randomized, controlled clinical trial. Successful outcome of this trial is expected to lead to the first autologous platelet concentrate with FDA approved wound healing claims, which could encourage widespread use of the applicants' device to augment wound healing. The affordability and convenience of the product being developed in this project will allow growth factor-mediated wound healing to reach diverse patient populations in a wide variety of situations from well-equipped operating rooms to minimally equipped remote battlefield medical units.

描述（由申请人提供）：作为伤口愈合的生化介质，人们对生长因子的作用有了改进的理解，为新的生物活性治疗产品系列铺平了道路，以加快伤口愈合。生长因子（重组或自体血小板）的递送已成为改善软，骨骼和结缔组织修复临床结果的可能商业机会。然而，由于目前的重组和自体血小板生长因子的产品非常昂贵，因此对加速伤口愈合的生长因素的广泛接受已受到阻碍，并且当前的自体血小板采购方法很麻烦且耗时。此外，目前的血小板收集设备均未批准伤口愈合的主张。申请人开发了一种简单且廉价的技术，可以快速从血液（<10分钟）中快速获得自体血小板浓缩物，而无需昂贵的设备。该过程已被表征和优化，以实现具有正常生长因子含量的高血小板，以及所得血小板浓缩物在体外加速细胞增殖中的安全性和功效，并改善了体内动物模型中的伤口愈合。该II阶段延续应用的目标是：（i）设计和制造一种自动化设备，该设备完全可容纳，以改善血小板恢复的鲁棒性并进一步最大程度地减少操作员的参与，以及（ii）建立收获的血小板浓度在促进皮肤伤口愈合方面的临床疗效。产品开发活动将包括计算机辅助设计和制造，快速原型制造，成型，组装，临床前测试，并建立质量保证计划，从而为设备的有限生产提供良好的制造实践。临床研究将使用基于FDA指导文件的方案来使用获得的血小板浓缩物治疗急性皮肤伤口和静脉溃疡，用于伤口愈合研究。这项研究的结果使用方便且负担得起的装置可以首次表明自体血小板浓缩物在加速皮肤伤口闭合基于前瞻性，随机，对照临床试验的加速性伤口。预计该试验的成功结果将导致首次使用FDA认可的伤口愈合主张的自体血小板浓缩液，这可以鼓励广泛使用申请人的装置来增强伤口愈合。该项目中开发的产品的负担能力和便利性将允许增长因子介导的伤口愈合，从而在各种情况下从设备齐全的手术室到设备齐全的远程战场医疗单位，以吸引各种各样的患者人群。