MAP: a Flowable, Precision-Engineered, and Tunable Tissue Scaffold Leveraging Hyper-Porous Geometry to Control Inflammation and Promote Regenerative Healing in Diabetic Wounds
MAP:一种可流动、精密设计且可调节的组织支架,利用超多孔几何形状来控制炎症并促进糖尿病伤口的再生愈合
基本信息
- 批准号:9909864
- 负责人:
- 金额:$ 73.71万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-09-15 至 2021-08-31
- 项目状态:已结题
- 来源:
- 关键词:AcuteAddressAdoptionAllograftingAlpha ParticlesAmputationAnimal ModelAreaAutomobile DrivingBandageBedsBiocompatible MaterialsBiologicalBiological FactorsBiomedical EngineeringBrainBreastCaliberCaringCellsCharacteristicsChemicalsChronicClinicalClinical DataClinical ResearchColonComplications of Diabetes MellitusCost SavingsDataDevelopmentDevicesDiabetic FootDiabetic Foot UlcerDiabetic woundEngineeringEnvironmentEvaluationExposure toFamily suidaeFormulationGeometryGranulation TissueGrowth FactorHealthcareHeartHistologicHydrogelsImpaired wound healingImpairmentInfectionInflammationInflammatory ResponseInjuryInstitutional Review BoardsInvestigationLightLower ExtremityMalignant NeoplasmsMechanicsMetaphorMicrospheresModelingMultiple TraumaNatural regenerationOutpatientsPathway interactionsPatient-Focused OutcomesPatientsPerformancePhasePoriferaPorosityProcessProstateRecurrenceReportingResearchRiskSafetyShapesSiteSkinSkin SubstitutesSterile coveringsStreptozocinStructureSurfaceTechniquesTechnologyTestingTherapeuticTimeLineTissue GraftsTissuesTranslatingTreatment CostVariantVascularizationVisitWorkWound Healinganimal tissuebasebiomaterial compatibilitychronic woundclinical developmentclinically relevantcostcost effectivediabeticdiabetic patientdiabetic wound healingfootgood laboratory practicehealingimprovedimproved outcomelimb amputationmortalitynext generationnovelparticleperformance testspost-marketpre-clinicalpressureregenerativesafety studyscaffoldscale uptissue regenerationtissue support framewound
项目摘要
SUMMARY / ABSTRACT
Chronic diabetic foot ulcers (DFUs) are a significant worldwide healthcare burden, reaching a cost of $11
billion in the US alone during 2014. The current treatment capability is limited by (i) inability of standard wet-to-
dry bandaging techniques to heal these wounds and (ii) the high costs of advanced treatments such as tissue-
based or living-cell bioengineered skin substitutes. The high costs of these treatments have limited
reimbursement until after a wound is chronic. Each year in the US, ~1.5 million new and continuing DFU cases
are documented. Over their lifetime, a diabetic patient with a foot wound has a 20% chance of lower limb
amputation in the US. Reported mortality rates for DFU patients range from 55 to 74% after 5 years, which are
above cancers such as prostate, breast, and colon.
This significant clinical need and lack of cost-effective products creates significant market opportunity that can
be addressed with a biomaterial therapy with the efficacy of an advanced skin substitute at the cost of a wound
dressing. Low product cost and ease-of-use will drive reimbursement and adoption in the early (acute) phase
of wound care in these at-risk diabetic patients. The ability to control inflammation and promote tissue ingrowth
could mitigate the chronic wound phase, improving outcomes for patients and reducing costs to payers. Until
now, there have been no low-cost treatments that when applied can integrate into the wound bed and promote
regeneration without cells or biologics.
To answer this market need, Tempo Therapeutics is developing a suite of tissue regeneration biomaterials
based on our proprietary Microporous Annealed Particle (MAP) technology. MAP allows us to empower
synthetic chemical formulations with unique geometric scaffold structure. Our MAP materials are flowable
(ease of application) and fill wounds of multiple shapes and sizes and convert to a hyper-porous sponge-like
network in the wound site after exposure to LED white light. The hyper-porosity geometry promotes fast tissue
ingrowth, early vascularization, and faster wound re-epithelialization when compared to leading decellularized
tissue-based matrices, with minimal inflammatory response.
Tempo has developed our first product, the MAP Wound Matrix, for treatment of acute healthy wounds and has
recently submitted a regulatory application via direct De Novo to FDA with safety and performance data.
Tempo has completed initial scale-up of product manufacturing and is preparing for post market clinical data
efforts beginning in 2019.
In the proposed direct-to-phase II work, we will develop our second product based on the MAP technology,
targeting impaired healing in diabetic wounds. We will employ specialized models of impaired wound healing in
diabetic pigs, performed under Good Laboratory Practices (GLP), to test a suite of three formulation variants
already demonstrated in a preliminary healthy swine study. The optimal formulation of MAP that performs in
slow healing environments and stimulates tissue regeneration will be selected for safety profiling and an
Investigational Device Exemption (IDE) will be submitted at the end of the proposal.
总结/摘要
慢性糖尿病足溃疡(DFU)是一个重大的全球医疗保健负担,达到11美元的成本
2014年仅在美国就有10亿美元。目前的处理能力受到以下限制:(i)标准湿-水处理系统的能力不足,
用于治愈这些伤口的干式包扎技术和(ii)高级治疗的高成本,
基于活细胞的生物工程皮肤替代品。这些治疗的高成本限制了
直到伤口愈合后才能报销。在美国,每年约有150万新发和持续的DFU病例
都记录在案在他们的一生中,足部伤口的糖尿病患者有20%的机会下肢受伤,
在美国截肢。报告的DFU患者5年后的死亡率范围为55%至74%,
高于前列腺癌乳腺癌和结肠癌
这种巨大的临床需求和缺乏具有成本效益的产品创造了巨大的市场机会,可以
以伤口为代价,采用具有高级皮肤替代品功效的生物材料治疗来解决
调味品。低产品成本和易用性将推动早期(急性)阶段的报销和采用
糖尿病高危患者的伤口护理。控制炎症和促进组织向内生长的能力
可以缓解慢性伤口阶段,改善患者的预后并降低支付者的成本。直到
现在,还没有低成本的治疗方法,当应用时,可以整合到伤口床中并促进
没有细胞或生物制剂的再生。
为了满足这一市场需求,克里思治疗公司正在开发一套组织再生生物材料
基于我们专有的微孔退火颗粒(MAP)技术。MAP使我们能够
具有独特几何支架结构的合成化学制剂。我们的MAP材料可流动
(ease并填充多种形状和尺寸的伤口,
在暴露于LED白色光后,伤口部位中的网状物。超高孔隙率的几何结构有助于快速组织
与导致脱细胞化相比,
组织基质,炎症反应最小。
克里思已开发出我们的第一个产品,MAP伤口基质,用于治疗急性健康伤口,并已
最近通过直接De Novo向FDA提交了监管申请,并提供了安全性和性能数据。
克里思已完成产品生产的初始规模扩大,并正在准备上市后临床数据
努力从2019年开始。
在拟议的直接进入第二阶段的工作中,我们将开发基于MAP技术的第二种产品,
靶向糖尿病伤口的受损愈合。我们将采用受损伤口愈合的专门模型,
糖尿病猪,根据药物非临床研究质量管理规范(GLP)进行,以检测一套三种制剂变体
已经在初步的健康猪研究中得到证实。MAP的最佳配方,
缓慢愈合环境和刺激组织再生将被选择用于安全性分析,
将在提案结束时提交试验用器械豁免(IDE)。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Stephanie Deshayes其他文献
Stephanie Deshayes的其他文献
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{{ truncateString('Stephanie Deshayes', 18)}}的其他基金
A first in human clinical study of TT101, a synthetic immunomodulatory material to build new functional tissue over exposed bone as a one time treatment for diabetic limb preservation patients
TT101 是一种合成免疫调节材料,可在暴露的骨骼上构建新的功能组织,作为糖尿病肢体保留患者的一次性治疗,这是首次进行人体临床研究
- 批准号:
10582523 - 财政年份:2021
- 资助金额:
$ 73.71万 - 项目类别:
A first in human clinical study of TT101, a synthetic immunomodulatory material to build new functional tissue over exposed bone as a one time treatment for diabetic limb preservation patients
TT101 是一种合成免疫调节材料,可在暴露的骨骼上构建新的功能组织,作为糖尿病肢体保留患者的一次性治疗,这是首次进行人体临床研究
- 批准号:
10326178 - 财政年份:2021
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$ 73.71万 - 项目类别:
Diversity supplement for Oliver Viyar to receive research training in tissue engineering.
奥利弗·维亚尔 (Oliver Viyar) 接受组织工程研究培训的多样性补充。
- 批准号:
10075090 - 财政年份:2019
- 资助金额:
$ 73.71万 - 项目类别:
MAP: a Flowable, Precision-Engineered, and Tunable Tissue Scaffold Leveraging Hyper-Porous Geometry to Control Inflammation and Promote Regenerative Healing in Diabetic Wounds
MAP:一种可流动、精密设计且可调节的组织支架,利用超多孔几何形状来控制炎症并促进糖尿病伤口的再生愈合
- 批准号:
10015273 - 财政年份:2019
- 资助金额:
$ 73.71万 - 项目类别:
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