Chondrofluid for arthroscopic knee cartilage repair
用于关节镜膝关节软骨修复的软骨液
基本信息
- 批准号:10761624
- 负责人:
- 金额:$ 25.21万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2023
- 资助国家:美国
- 起止时间:2023-09-21 至 2024-08-31
- 项目状态:已结题
- 来源:
- 关键词:AccelerationAddressAdolescentAdoptionAdultAllogenicAnimalsAnkleArthralgiaArthroscopyBiochemistryBiomechanicsCartilageCell SurvivalCell hybridizationCharacteristicsChondrocytesClinicalDataDefectDeteriorationEngineeringEvaluationFemurFluorescent in Situ HybridizationFormulationGaitGelHeatingHip region structureHistologyHumanImmunohistochemistryImplantInjectableInjuryJointsKneeLeftLegal patentLesionLiquid substanceMechanicsMedialMeniscus structure of jointMetabolicMiniature SwineMinorModelingMonitorOrthopedic SurgeryOutcome AssessmentPainPatientsPhaseRecoveryRehabilitation therapySafetySecond Look SurgerySerologyShapesSpeedStructureSurfaceSurgeonSynovial FluidTechniquesTechnologyTemperatureTestingThickTissue EngineeringValidationVisualizationarticular cartilagecartilage implantcartilage regenerationcartilage repairclinically relevantcommercializationdesignhealingin vivoin vivo evaluationinfection riskliquid crystalminimally invasivepain scalepre-clinicalpreclinical studypreventprimary endpointrepair modelrepair strategyrepairedresearch clinical testingresponserib bone structuresample fixationscaffoldsecondary endpointself assemblytechnology platformtissue repairtreatment grouptreatment strategy
项目摘要
PROJECT SUMMARY
Minor injuries to articular cartilage can initiate a catabolic cascade, causing small defects to progress into larger,
more symptomatic defects. Pain, lesion progression, and accelerated joint deterioration may be avoided with
strategies that repair small defects with hyaline-like cartilage. The repair of chondral defects using arthroscopic
techniques, performed in a minimally invasive manner, has advantages over traditional open approaches due to
enhanced access and visualization in the joint, lower risk of infection, and quicker recovery. For the hip and
ankle, arthroscopic cartilage repair is particularly attractive because these joints are difficult to access with open
approaches. To address the need for an effective arthroscopic cartilage repair treatment, Cartilage Inc. has
developed Chondrofluid™, an injectable, biologically active, off-the-shelf cartilage repair product that can be
easily applied arthroscopically to any chondral defect on the femoral and tibial surfaces. Chondrofluid™ is
derived from active, juvenile, allogeneic, costal (rib) chondrocytes using Cartilage Inc.’s patent-pending platform
technologies. At 4ºC, Chondrofluid’s™ liquid form allows it to flow into every crevice of cartilage defects.
Arthroscopic delivery into the body raises Chondrofluid™ past the critical micellization temperature of its
components, causing the self-assembly of cubic lyotropic liquid crystal structures that turn Chondrofluid™ into a
gel, allowing it to attach and lock itself into defects. Ex vivo application of Chondrofluid™ to partial-thickness
defects showed excellent repair tissue fill that integrated into the native cartilage. In vivo, preliminary data show
that Chondrofluid™ fills gouge defects with neocartilage and integrates tissue engineered implants to native
cartilage when applied using open arthrotomy onto defects on the femoral trochlea. The Chondrofluid™
formulation has been modified for arthroscopic approaches, and, toward the regulatory approval of
Chondrofluid™ for arthroscopic use, in vivo validation is needed. Using a preclinical minipig model, this proposal
investigates the arthroscopic treatment of two types of clinically relevant chondral lesions in the knee using
Chondrofluid-MP (minipig cellular product analogous to Chondrofluid). First, a partial thickness, linear, gouge
defect of the medial femoral condyle will be arthroscopically created and treated with injectable Chondrofluid-
MP, or microfracture (positive control), or left empty (negative control) arthroscopically. Second, full-thickness,
small (8x4 mm, which is equivalent to a critical size 1 cm2 defect in the human knee) tibial defects will be
arthroscopically created on the medial tibial plateau and treated with Chondrofluid-MP, or microfracture (positive
control), or left empty (negative control) arthroscopically.
项目总结
项目成果
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