Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06775600

Stem Cell Isolation From Femoral Heads Post Total Hip Arthroplasty

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Obesity and Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hip replacement

Procedure

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

Primary outcomes

  1. Cell Yield

    Time frame: Within 24 hours of surgery

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

  2. Cellular Growth Kinetics

    Time frame: 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.

  3. Cellular Phenotype

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Caleb J Podgers

CONTACT

[email protected]

343-364-4014

David A Hess, PhD

CONTACT

[email protected]

519.931.5777 ext. 24118

Sponsors and collaborators

Lead sponsor

David Hess

Other

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.