Stem Cell Isolation From Femoral Heads Post Total Hip Arthroplasty

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity and Type 2 Diabetes
• Intervention / Treatment: Procedure: Hip Replacement

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David A Hess, PhD; Phone Number: 24118 519.931.5777; Email: dhess3@uwo.ca
• Study Contact Backup: Name: Caleb J Podgers; Phone Number: 343-364-4014; Email: cpodgers@uwo.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Type-2 Diabetes; Cells are harvested from individuals with Type-2 Diabetes	Procedure: Hip Replacement; Total Hip Arthroplasty where the Femoral Head will be used to harvest stem cells post-extrication from the individual.
Experimental: Obesity; Cells are Harvested from individuals with obesity	Procedure: Hip Replacement; Total Hip Arthroplasty where the Femoral Head will be used to harvest stem cells post-extrication from the individual.
Experimental: Non-Type-2 Diabetic and Non-Obese Controls; Cells are harvested from individuals with no Type-2 Diabetes and no Obesity	Procedure: Hip Replacement; Total Hip Arthroplasty where the Femoral Head will be used to harvest stem cells post-extrication from the individual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: David Hess
• Investigators: Principal Investigator: David A Hess, PhD, Western University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Diabetes; Obesity; Stem Cell; Regeneration
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity
• Other Study ID Numbers: 125884

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared, unless disseminated in study publication. This is to protect the study participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No