Stem Cell Isolation From Femoral Heads Post Total Hip Arthroplasty

NCT06775600 | Not Yet Recruiting

• 1 other identifier: 125884
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Obesity and Type 2 Diabetes

Keywords

Stem Cell; Diabetes; Obesity; Regeneration

Outcome Measures

Primary Outcomes (3)

• Cell Yield

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

  Within 24 hours of surgery

• Cellular Growth Kinetics

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

  Time of cell harvest to 8 weeks post harvest

• Cellular Phenotype

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

  Time of cell harvest to 8 weeks post harvest

Study Arms (3)

Type-2 Diabetes

EXPERIMENTAL

Cells are harvested from individuals with Type-2 Diabetes

Procedure: Hip Replacement

Obesity

EXPERIMENTAL

Cells are Harvested from individuals with obesity

Procedure: Hip Replacement

Non-Type-2 Diabetic and Non-Obese Controls

EXPERIMENTAL

Cells are harvested from individuals with no Type-2 Diabetes and no Obesity

Procedure: Hip Replacement

Interventions

Hip Replacement PROCEDURE

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

Non-Type-2 Diabetic and Non-Obese Controls; Obesity; Type-2 Diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be 18+ years of age

You may not qualify if:

• 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

Sponsors & Collaborators

• David Hess: lead

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• David A Hess, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Hess, PhD

CONTACT

519.931.5777; dhess3@uwo.ca

Caleb J Podgers

CONTACT

343-364-4014; cpodgers@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. David Hess

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 15, 2025
• Study Start: February 1, 2025
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share