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临床试验/NCT06775600
NCT06775600尚未招募不适用

Harvest of Human Bone Marrow-Derived Progenitor Cells During Total Hip Arthroplasty for Use in Regenerative Medicine Applications for Blood Vessel and Islet Regeneration.

David Hess0 个研究点目标入组 30 人开始时间: 2025年2月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
主要终点
Cell Yield

研究概览

简要总结

Femoral heads will be collected at University Hospital (London, ON, Canada) from individuals with type-2 diabetes, obesity, and no T2D/no obesity controls. The femoral head will be taken to the Robarts Research Institute (London, ON, Canada) for lineage-restricted progenitor cell expansion and analyses. There the femoral heads will be used to isolate three stem cell types - Multipotent Stromal Cells, Endothelial Colony Forming Cells, and Hematopoietic Progenitor Cells. The yield and cell surface markers expressed on these cells will be measured using flow cytometry. These cell types will then undergo further analyses of the secretome, tubule forming assays, vascular regenerative cell exhaustion assays, and will be transplanted into immune deficient mice with with femoral artery ligation. These experiments are to assess the differences in function and expression of these cell types between individuals with type-2 diabetes and/or obesity and/or healthy controls.

详细描述

Femoral Heads will be extracted by Dr. Lanting (Department of Surgery - Division of Orthopaedics) at University Hospital, they will then be transferred to Robarts Research Institute where they will undergo cell isolation and analyses. Multipotent Stromal Cells, Endothelial Colony Forming Cells, and Hematopoietic Progenitor Cells will be extracted from the bone marrow of the femoral heads. These cells will be used to characterize the difference in regenerative progenitor cell number and potential dysfunction in individuals with type 2 diabetes and/or obesity compared to controls. Analysis will include growth kinetics, flow cytometry, Bio Luminescent Imaging and Laser Doppler Perfusion Imaging using a FAL mouse model.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Must be 18+ years of age

排除标准

  • Diagnosis of bone cancers
  • Diagnosis of Rheumatoid arthritis
  • Diagnosis of hematopoietic conditions
  • Diagnosis of avascular necrosis of the hip
  • does not fall within BMI requirements for experimental groups
  • Cannot read and/or speak in english

结局指标

主要结局

Cell Yield

时间窗: Within 24 hours of surgery

Quantification of how many cells are harvested from each femoral head prior to expansion in vitro

Cellular Growth Kinetics

时间窗: Time of cell harvest to 8 weeks post harvest

Quantification of the Growth Kinetics of each cell type during in vitro cell culture post cell harvest.

Cellular Phenotype

时间窗: Time of cell harvest to 8 weeks post harvest

Analysis via flow cytometry of the phenotype of each cell type and their respective surface markers that are involved in regenerative pathways.

次要结局

未报告次要终点

研究者

发起方
David Hess
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Hess

Dr. David Hess

Western University, Canada

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