Injectable collagen crosslink augmentation for degenerative disc disease

可注射胶原交联增强治疗退行性椎间盘疾病

基本信息

  • 批准号:
    8018638
  • 负责人:
  • 金额:
    $ 35.94万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2007
  • 资助国家:
    美国
  • 起止时间:
    2007-08-15 至 2012-07-31
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): With regard to prevalence and cost to society, low-back pain has few peers. With a patient population in excess of 15 million/year, the societal cost is estimated to be in the realm of $100 billion/year. Current treatment options for this disease have shown limited success, including physical therapy, medication and surgery. This proposal involves a novel, nonsurgical and cost-effective, tissue revitalization approach which shows promise for treatment of mechanically and nutritionally challenged tissues like the spinal disc. Previous in vitro and in vivo studies have demonstrated the efficacy of Injectable collagen crosslink augmentation in stabilizing spinal joints, decreasing disc bulge under load, increasing the strength, tear resistance, and durability of the tissue, while also improving nutritional flow to these largely avascular tissues. Phase I testing was successful in characterizing the crosslinking effects of seven candidate agents in disc annulus fibrosis (AF) tissue using mechanical, thermal and protease digestion assays. At least one preferred agent was identified, and concentration, pH, conditioning, and buffering were optimized to maximize the efficiency of crosslinking and mechanical effect. Recently, in vitro assays have been undertaken to determine agent and buffer biocompatibility. The proposed Phase II testing will provide data necessary for regulatory filings and first-in-man clinical trials. Reagent delivery, penetration, reaction kinetics, permanency (effect duration), and storage requirements (shelf life) will be thoroughly investigated. Acute, functional biocompatibility and neurotoxicity studies will be conducted to quantify expected and worst-case treatment effects in an animal model. Further characterization of crosslinking effects will be determined using different subgroups of human AF tissues (variations in age, composition, degeneration). By bringing this path-breaking treatment to the doorstep of clinical trials, SBIR funding will play a vital role in enabling progress towards the ultimate goal of providing a novel, cost-effective treatment in the struggle against low back pain and disability. PUBLIC HEALTH RELEVANCE: Back pain and disability associated with spinal degeneration and instability remains among the most costly and prevalent health problems in the US today. With a patient population in excess of 15 million/year, the societal cost is estimated to be in the realm of $100 billion/year. Due to the limited success of current treatment options, it is reasonable to expect that an effective nonsurgical solution could revolutionize clinical care for this pandemic.
描述(由申请人提供): 就流行率和社会成本而言,腰痛是罕见的。由于每年患者人数超过 1500 万,社会成本估计达到每年 1000 亿美元。目前针对这种疾病的治疗方案,包括物理治疗、药物治疗和手术,效果有限。该提案涉及一种新颖的、非手术且具有成本效益的组织再生方法,该方法有望治疗椎间盘等机械和营养困难的组织。先前的体外和体内研究已经证明了可注射胶原交联增强剂在稳定脊柱关节、减少负载下椎间盘突出、增加组织的强度、抗撕裂性和耐久性方面的功效,同时还改善了这些基本上无血管组织的营养流动。第一阶段测试成功地利用机械、热和蛋白酶消化测定法表征了七种候选药物在椎间盘纤维化 (AF) 组织中的交联效应。确定了至少一种优选试剂,并优化了浓度、pH、调节和缓冲,以最大限度地提高交联效率和机械效应。最近,已经进行了体外测定以确定试剂和缓冲液的生物相容性。拟议的二期测试将为监管备案和首次人体临床试验提供必要的数据。将彻底研究试剂输送、渗透、反应动力学、持久性(作用持续时间)和储存要求(保质期)。将进行急性、功能性生物相容性和神经毒性研究,以量化动物模型中的预期和最坏情况治疗效果。交联效应的进一步表征将使用人类 AF 组织的不同亚组(年龄、成分、退化的变化)来确定。通过将这种开创​​性的治疗方法引入临床试验,SBIR 资金将在实现最终目标方面发挥至关重要的作用,即提供一种新颖的、具有成本效益的治疗方法来对抗腰痛和残疾。 公共卫生相关性:与脊柱退化和不稳定相关的背痛和残疾仍然是当今美国最昂贵和最普遍的健康问题之一。由于每年患者人数超过 1500 万,社会成本估计达到每年 1000 亿美元。由于当前治疗方案的成功有限,有理由预期有效的非手术解决方案可能会彻底改变这一流行病的临床护理。

项目成果

期刊论文数量(3)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
Kinetic Analysis of Genipin Degradation in Aqueous Solution
  • DOI:
    10.1177/1934578x1000501202
  • 发表时间:
    2010-12
  • 期刊:
  • 影响因子:
    1.8
  • 作者:
    P. Slusarewicz;Keng Zhu;T. Hedman
  • 通讯作者:
    P. Slusarewicz;Keng Zhu;T. Hedman
Changes in the interfacial shear resistance of disc annulus fibrosus from genipin crosslinking.
  • DOI:
    10.1016/j.jbiomech.2013.10.019
  • 发表时间:
    2014-01-03
  • 期刊:
  • 影响因子:
    2.4
  • 作者:
    Kirking, Bryan;Hedman, Thomas;Criscione, John
  • 通讯作者:
    Criscione, John
The dose response relationship between intervertebral disc flexion-extension neutral zone metrics and injected genipin concentration.
椎间盘屈伸中性区指标与注射京尼平浓度之间的剂量反应关系。
{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ monograph.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ sciAawards.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ conferencePapers.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ patent.updateTime }}

THOMAS P HEDMAN其他文献

THOMAS P HEDMAN的其他文献

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

{{ truncateString('THOMAS P HEDMAN', 18)}}的其他基金

Crosslink augmentation to resist snoring and obstructive sleep apnea syndrome
交联增强可抵抗打鼾和阻塞性睡眠呼吸暂停综合症
  • 批准号:
    8452036
  • 财政年份:
    2013
  • 资助金额:
    $ 35.94万
  • 项目类别:
Nonsurgical Exogenous Crosslink Therapy for Intervertebral Disc Disease
椎间盘疾病的非手术外源性交联疗法
  • 批准号:
    7272176
  • 财政年份:
    2007
  • 资助金额:
    $ 35.94万
  • 项目类别:
Injectable collagen crosslink augmentation for degenerative disc disease
可注射胶原交联增强治疗退行性椎间盘疾病
  • 批准号:
    7800652
  • 财政年份:
    2007
  • 资助金额:
    $ 35.94万
  • 项目类别:
Modification of Intervertebral Disk Fatigue Resistance
椎间盘抗疲劳性的改进
  • 批准号:
    6403094
  • 财政年份:
    2001
  • 资助金额:
    $ 35.94万
  • 项目类别:

相似海外基金

Rational design of rapidly translatable, highly antigenic and novel recombinant immunogens to address deficiencies of current snakebite treatments
合理设计可快速翻译、高抗原性和新型重组免疫原,以解决当前蛇咬伤治疗的缺陷
  • 批准号:
    MR/S03398X/2
  • 财政年份:
    2024
  • 资助金额:
    $ 35.94万
  • 项目类别:
    Fellowship
Re-thinking drug nanocrystals as highly loaded vectors to address key unmet therapeutic challenges
重新思考药物纳米晶体作为高负载载体以解决关键的未满足的治疗挑战
  • 批准号:
    EP/Y001486/1
  • 财政年份:
    2024
  • 资助金额:
    $ 35.94万
  • 项目类别:
    Research Grant
CAREER: FEAST (Food Ecosystems And circularity for Sustainable Transformation) framework to address Hidden Hunger
职业:FEAST(食品生态系统和可持续转型循环)框架解决隐性饥饿
  • 批准号:
    2338423
  • 财政年份:
    2024
  • 资助金额:
    $ 35.94万
  • 项目类别:
    Continuing Grant
Metrology to address ion suppression in multimodal mass spectrometry imaging with application in oncology
计量学解决多模态质谱成像中的离子抑制问题及其在肿瘤学中的应用
  • 批准号:
    MR/X03657X/1
  • 财政年份:
    2024
  • 资助金额:
    $ 35.94万
  • 项目类别:
    Fellowship
CRII: SHF: A Novel Address Translation Architecture for Virtualized Clouds
CRII:SHF:一种用于虚拟化云的新型地址转换架构
  • 批准号:
    2348066
  • 财政年份:
    2024
  • 资助金额:
    $ 35.94万
  • 项目类别:
    Standard Grant
BIORETS: Convergence Research Experiences for Teachers in Synthetic and Systems Biology to Address Challenges in Food, Health, Energy, and Environment
BIORETS:合成和系统生物学教师的融合研究经验,以应对食品、健康、能源和环境方面的挑战
  • 批准号:
    2341402
  • 财政年份:
    2024
  • 资助金额:
    $ 35.94万
  • 项目类别:
    Standard Grant
The Abundance Project: Enhancing Cultural & Green Inclusion in Social Prescribing in Southwest London to Address Ethnic Inequalities in Mental Health
丰富项目:增强文化
  • 批准号:
    AH/Z505481/1
  • 财政年份:
    2024
  • 资助金额:
    $ 35.94万
  • 项目类别:
    Research Grant
ERAMET - Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
ERAMET - 快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
  • 批准号:
    10107647
  • 财政年份:
    2024
  • 资助金额:
    $ 35.94万
  • 项目类别:
    EU-Funded
Ecosystem for rapid adoption of modelling and simulation METhods to address regulatory needs in the development of orphan and paediatric medicines
快速采用建模和模拟方法的生态系统,以满足孤儿药和儿科药物开发中的监管需求
  • 批准号:
    10106221
  • 财政年份:
    2024
  • 资助金额:
    $ 35.94万
  • 项目类别:
    EU-Funded
Recite: Building Research by Communities to Address Inequities through Expression
背诵:社区开展研究,通过表达解决不平等问题
  • 批准号:
    AH/Z505341/1
  • 财政年份:
    2024
  • 资助金额:
    $ 35.94万
  • 项目类别:
    Research Grant
{{ showInfoDetail.title }}

作者:{{ showInfoDetail.author }}

知道了