Clinical trial NCT06775600: Stem Cell Isolation From Femoral Heads Post Total Hip Arthroplasty
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity and Type 2 Diabetes
Keywords: Stem Cell
Diabetes
Obesity
Regeneration
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Cell Yield
timeFrame: Within 24 hours of surgery
measure: Cellular Growth Kinetics
timeFrame: Time of cell harvest to 8 weeks post harvest
measure: Cellular Phenotype
timeFrame: Time of cell harvest to 8 weeks post harvest
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Western University
name: David A Hess, PhD
role: PRINCIPAL_INVESTIGATOR
References: