Adipose-Derived Stromal/Stem Cell Therapy for Pressure Ulcers

脂肪源性基质/干细胞治疗压疮

基本信息

批准号：
9339502
负责人：
Jeffrey Martin Gimble
金额：
$ 60.99万
依托单位：
LACELL, LLC
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-01 至 2019-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9339502
关键词：
Address Adipose tissue Age Age-Years Aging Allogenic American Animal Model Architecture Assisted Living Facilities Biological Assay Biotechnology Blood Vessels Brain Budgets C57BL/6 Mouse Care given by nurses Cell Fraction Cell Separation Cell Therapy Cells Clinical Clinical Data Clinical Trials Collaborations Data Debridement Decubitus ulcer Dependency Dermal Detection Developed Countries Developing Countries Development Devices Diabetic wound Distant Dose Economics Elderly Etiology FDA approved Female Fibroblasts Flow Cytometry Foundations Funding Geriatrics Grant Health Care Costs Healthcare Heart Histology Hospital Costs Hospitalization Hour Human Hyperbaric Oxygen Immunocompetent In Situ In Vitro Infiltration Inflammatory Injection of therapeutic agent Injury Investigation Ischemia Joints Kidney Laboratories Length Licensing Life Link Liver Lung Lymphangiogenesis Malnutrition Manufacturer Name Manuscripts Medical Memorial Sloan-Kettering Cancer Center Molecular Profiling Monitor Morphology Mus Natural regeneration Nursing Homes Operative Surgical Procedures Organ Outcome Patients Peer Review Periodicity Phase Pilot Projects Positioning Attribute Procedures Process Protocols documentation Publishing Publishing Peer Reviews Quadriplegia Quality of life Quantitative Reverse Transcriptase PCR Recovery Reperfusion Therapy Reporting Research Design Risk SCID Beige Mouse Safety Skin Skin Temperature Skin Tissue Small Business Innovation Research Grant South Korea Spinal cord injury patients Stem cells Surface Surveys System Technology Temperature Testing Therapeutic Time Tissues Topical application Translating Translational Research Ulcer United States Food and Drug Administration Universities Validation age group angiogenesis base bench to bedside care burden clinical translation cost cytokine experience healing high risk improved mRNA Expression male man medical attention meetings migration molecular marker mouse model novel platelet-derived growth factor BB point of care pre-clinical preclinical study pressure pressure ulcer prevention public health relevance regenerative repaired response sex skin regeneration stem cell therapy wound wound closure

项目摘要

DESCRIPTION (provided by applicant): This Phase II SBIR extends a Phase I proof of principle study originally submitted in response to RFA-AG-12-009 entitled "T1 Translational Research on Aging" from the NIA. In Phase I, LaCell has documented pre-clinical safety and efficacy of a novel adipose derived cell therapy for the treatment of pressure ulcers in young and old mice. The injection of murine ASC significantly accelerated and enhanced pressure ulcer repair in female mice of both age groups in a dose dependent manner as evidenced by the rate of wound closure, re-epithelialization, skin tissue architecture, inflammatory cell infiltratin and expression of molecular biomarkers. LaCell's studies pave the way for clinical translation and regulatory approval of ASC therapies. While it is well established that the prevention of pressure ulcers requires labor-intensive nursing care, patients in assisted living centers and nursing homes remain at high risk for developing pressure ulcers. Over 70% of pressure ulcers occur in Americans over the age of 70 and their hospital costs exceed $11 billion annually. Current treatment of pressure ulcers relies primarily on surgical debridement, hyperbaric oxygen, and negative pressure devices. The adipose derived- cell based therapies have the potential to substantially reduce the length of hospitalization and associated health care costs for pressure ulcer patients. LaCell has partnered with a Tissue Genesis, Inc., to use their established ICellator device to obtain clinical grade human SVF cells. This strategic partnership will accelerate the clinical translation of LaCell's cell therapeutic to the marketplace. Specific Aims (SA) will address pharmacotoxicology regulatory concerns in murine models and serve as a definitive protocol to the Food and Drug Administration for an Investigational Device Exemption in the case of SVF cells (SA1) and a Biologics License Application in the case of ASC (SA2). Each SA will evaluate the concentration dependency of human SVF cells and ASC in the treatment of a murine pressure ulcer therapy in immunodeficient and immunocompetent mice of both sexes; both young and old immunocompetent mice will be evaluated. Injection of PBS alone or with human dermal fibroblasts will serve as negative controls while topical application of the FDA approved diabetic wound therapeutic, beclapermin (PDGF-BB) will serve as a positive control. Quantitative outcomes will include rate of wound closure, inflammatory cell infiltration, pro-inflammatory cytokine expression, and immunohistochemical detection of human cells in situ. Since pressure ulcer treatment accounts for 1- 4% of the total health care budget in developed nations, LaCell's developing technologies have considerable market potential.

描述（由申请人提供）：该 II 期 SBIR 扩展了最初为响应 NIA 题为“T1 衰老转化研究”的 RFA-AG-12-009 而提交的 I 期原理研究证明。在 I 期中，LaCell 已记录。一种新型脂肪来源细胞疗法治疗年轻和年老小鼠压疮的临床前安全性和有效性注射小鼠 ASC 显着加速和增强了雌性小鼠的压疮修复。 LaCell 的研究以剂量依赖性方式对 ASC 疗法的临床转化和监管批准铺平了道路。众所周知，预防压疮需要劳动密集型护理，但辅助生活中心和疗养院的患者仍然面临着发生压疮的高风险，超过 70% 的压疮发生在超过 70 岁的美国人中。 70 人，他们的医院每年花费 110 亿美元。目前压疮的治疗主要依靠手术清创、高压氧和负压设备。基于脂肪的细胞疗法有可能大大缩短住院时间和相关健康。 LaCell 与 Tissue Genesis, Inc. 合作，使用其成熟的 ICellator 设备获取临床级人类 SVF 细胞。这一战略合作伙伴关系将加速 LaCell 细胞治疗的临床转化。具体目标 (SA) 将解决小鼠模型中的药物毒理学监管问题，并作为美国食品和药物管理局关于 SVF 细胞 (SA1) 的研究设备豁免和生物制剂许可申请的最终协议。 ASC 病例 (SA2) 将评估人类 SVF 细胞和 ASC 在免疫缺陷和免疫功能正常的两性小鼠中治疗小鼠压疮的浓度依赖性；单独注射 PBS 或与人真皮成纤维细胞注射的免疫活性小鼠将作为阴性对照，而局部应用 FDA 批准的糖尿病伤口治疗剂 Beclapermin (PDGF-BB) 将作为阳性对照。伤口闭合、炎症细胞浸润、促炎细胞因子表达以及人体细胞原位免疫组织化学检测，因为压疮治疗占总医疗保健预算的 1-4%。在对于发达国家来说，LaCell的开发技术具有相当大的市场潜力。