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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.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06775600
Enrollment
30
Registered
2025-01-15
Start date
2025-02-01
Completion date
2025-08-01
Last updated
2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity and Type 2 Diabetes

Keywords

Stem Cell, Diabetes, Obesity, Regeneration

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.

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

PROCEDUREHip Replacement

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

Sponsors

David Hess
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cell YieldWithin 24 hours of surgeryQuantification of how many cells are harvested from each femoral head prior to expansion in vitro
Cellular Growth KineticsTime of cell harvest to 8 weeks post harvestQuantification of the Growth Kinetics of each cell type during in vitro cell culture post cell harvest.
Cellular PhenotypeTime of cell harvest to 8 weeks post harvestAnalysis via flow cytometry of the phenotype of each cell type and their respective surface markers that are involved in regenerative pathways.

Contacts

Primary ContactDavid A Hess, PhD
dhess3@uwo.ca519.931.5777
Backup ContactCaleb J Podgers
cpodgers@uwo.ca343-364-4014

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026