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Not yet recruiting NCT06775600

Stem Cell Isolation From Femoral Heads Post Total Hip Arthroplasty

No phase Interventional Obesity and Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Hip Replacement.
Who it may be relevant to
Registry conditions: Obesity and Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Procedure Hip Replacement
    Total Hip Arthroplasty where the Femoral Head will be used to harvest stem cells post-extrication from the individual.

Primary outcome measures

  • Cell Yield [Time frame: Within 24 hours of surgery]
  • Cellular Growth Kinetics [Time frame: Time of cell harvest to 8 weeks post harvest]
  • Cellular Phenotype [Time frame: Time of cell harvest to 8 weeks post harvest]

Eligibility criteria

Inclusion criteria

  • Must be 18+ years of age

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Basic science

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06775600 · 125884

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗