Innovation of Skin Banking and Transplantation Based on a First-in-Class Biocompatible Cryopreservation Technology
基于一流的生物相容性冷冻保存技术的皮肤库和移植创新
基本信息
- 批准号:10618957
- 负责人:
- 金额:$ 73.63万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-05-06 至 2025-04-30
- 项目状态:未结题
- 来源:
- 关键词:AmericanArtificial IntelligenceAttributes of ChemicalsAutologous TransplantationAwardBandageBig DataBiological AssayBirthCellsChemicalsClinicalCollaborationsCollagenContractsCoupledCryopreservationCryopreserved TissueDNA Sequence AlterationData SetDevicesDimethyl SulfoxideDomestic PigElectronsEnzyme-Linked Immunosorbent AssayEvaluationFamily suidaeFeedbackFoundationsFutureGlycerolGoalsGood Manufacturing ProcessGrowth FactorHealthHealthcare IndustryHistologyHumanImmunogeneticsIn Situ Nick-End LabelingIn VitroIndustrializationIndustryKnock-outLettersMarketingMedicineMethodsMicroscopicMissouriOrgan ProcurementsOsmosisOutcomeProceduresProcessProductionProtocols documentationQualifyingResearchResearch ContractsResourcesSafetySecureSkinSkin TransplantationSkin graftSmall Business Innovation Research GrantStainsStandardizationTechnologyTestingTissue BanksTissue DonorsTissue ProcurementsTissue TransplantationTissue ViabilityToxic effectTrademarkTransplantationUnited States National Institutes of HealthUniversitiesWorkXenograft procedurebiobankbiomaterial compatibilityclinical carecommercial prototypecommercializationefficacy evaluationevaluation/testingexperiencehealingimprovedin vivoin vivo Modelin vivo evaluationinnovationinventionmanufacturing organizationmedical schoolsnoveloperationpreservationpreventsmall molecule
项目摘要
SUMMARY
Previous support from NIH SBIR and Coulter Foundation awards allowed the CryoCrate team to develop a first-
in-class biocompatible cryopreservation medium product, trademarked as OdinSol®, that will provide efficient
options for biobanking practices associated with storage of skin grafts from donors or xenotransplants.
The OdinSol® technology removes the need for any toxic cell permeating cryoprotectant used in all existing
tissue cryopreservation methods, considerably simplifies associated operations, and more importantly, secures
the outcome of long-term storage in regular -80oC deep freezers by preventing gradual cell loss.
Based on our former experience in FDA 510(k) submission, in this project, we organized the collaboration with
our regulatory consultant (Cardinal Health), contract manufacturing organizations (Bryllan), contract research
organization (WuXi AppTec), academic collaborator (University of Missouri Department of Medicine and National
Swine Research and Research Center), to achieve the following milestones:
I. The production of OdinSol® meets GMP qualifications and biocompatibility assessment shows
compliance with FDA guidance for 510(k) submission as a storage device for transplantable tissues;
II. The in vitro and in vivo evaluation of safety and efficacy demonstrates the OdinSol® technology to be
superior to existing cryopreservation protocols with respect to preserving viability and function of skin
grafts;
III. Based on those qualifications, we will complete of the 510(k) submission and finalize of the production
line based on further FDA feedback before the end of the project period.
We expect future clinical use of the OdinSol® technology within three years after the FDA clearance, providing
the skin banking and xenotransplantation industry with a highly efficient biocompatible cryostorage platform.
概括
先前来自 NIH SBIR 和库尔特基金会奖项的支持使 CryoCrate 团队能够开发出第一个-
一流的生物相容性冷冻保存介质产品,商标为 OdinSol®,将提供高效
与储存捐赠者的皮肤移植物或异种移植物相关的生物样本库实践的选择。
OdinSol® 技术消除了所有现有技术中使用的任何有毒细胞渗透冷冻保护剂的需要
组织冷冻保存方法,大大简化了相关操作,更重要的是,安全
通过防止细胞逐渐损失,在常规 -80oC 冷冻柜中长期储存的结果。
根据我们之前提交 FDA 510(k) 的经验,在这个项目中,我们组织了与
我们的监管顾问 (Cardinal Health)、合同制造组织 (Bryllan)、合同研究
组织(药明康德)、学术合作者(密苏里大学医学系和国家
养猪研究中心),实现以下里程碑:
一、OdinSol®的生产符合GMP资质及生物相容性评估表明
符合 FDA 关于 510(k) 提交的指南,作为可移植组织的存储设备;
II. 安全性和有效性的体外和体内评估表明 OdinSol® 技术是
在保留皮肤的活力和功能方面优于现有的冷冻保存方案
移植物;
III. 根据这些资格,我们将完成 510(k) 提交并完成制作
线基于项目期结束前 FDA 的进一步反馈。
我们预计 OdinSol® 技术在获得 FDA 批准后三年内可用于未来的临床应用,从而提供
皮肤库和异种移植行业拥有高效的生物相容性低温储存平台。
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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{{ truncateString('Xu Han', 18)}}的其他基金
Innovation of Biobanking for Cellular Adoptive Immunotherapies Based on a First-in-Class Biocompatible Cryopreservation Technology for T and NK Cells and Their CAR-Engineered Products
基于 T 细胞和 NK 细胞及其 CAR 工程产品的一流生物相容性冷冻保存技术的细胞过继免疫疗法生物库创新
- 批准号:
10611789 - 财政年份:2022
- 资助金额:
$ 73.63万 - 项目类别:
Innovation of Biobanking for Cellular Adoptive Immunotherapies Based on a First-in-Class Biocompatible Cryopreservation Technology for T and NK Cells and Their CAR-Engineered Products
基于 T 细胞和 NK 细胞及其 CAR 工程产品的一流生物相容性冷冻保存技术的细胞过继免疫疗法生物库创新
- 批准号:
10705271 - 财政年份:2022
- 资助金额:
$ 73.63万 - 项目类别:
Late-stage Preclinical Development and cGMP Production of a First-in-Class Cornea Cryopreservation Kit Based on FDA Feedback
根据 FDA 反馈,对一流的角膜冷冻保存试剂盒进行后期临床前开发和 cGMP 生产
- 批准号:
10326323 - 财政年份:2021
- 资助金额:
$ 73.63万 - 项目类别:
A Novel Cryopreservation Technology for Large Skin Grafts to Facilitate Tissue Banking and Allograft Transplantations
一种用于大型皮肤移植物的新型冷冻保存技术,以促进组织库和同种异体移植
- 批准号:
10011745 - 财政年份:2020
- 资助金额:
$ 73.63万 - 项目类别:
An Ultra-fast Cooling Device for Vitrification and Cryopreservation of Cells and Tissues
用于细胞和组织玻璃化和冷冻保存的超快速冷却装置
- 批准号:
10221208 - 财政年份:2015
- 资助金额:
$ 73.63万 - 项目类别:
An Ultra-fast Cooling Device for Vitrification and Cryopreservation of Cells and Tissues
用于细胞和组织玻璃化和冷冻保存的超快速冷却装置
- 批准号:
10006333 - 财政年份:2015
- 资助金额:
$ 73.63万 - 项目类别:
An Ultra-fast Cooling Device for Vitrification and Cryopreservation of Cells and Tissues
用于细胞和组织玻璃化和冷冻保存的超快速冷却装置
- 批准号:
8834867 - 财政年份:2015
- 资助金额:
$ 73.63万 - 项目类别:
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