Stem Cell Isolation From Femoral Heads Post Total Hip Arthroplasty

David Hess

Status: Not yet enrolling

Conditions: Obesity and Type 2 Diabetes

Treatments: Procedure: Hip Replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT06775600

125884

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

30 participants in 3 patient groups

Type-2 Diabetes

Experimental group

Description:

Cells are harvested from individuals with Type-2 Diabetes

Treatment:

Procedure: Hip Replacement

Obesity

Experimental group

Description:

Cells are Harvested from individuals with obesity

Treatment:

Procedure: Hip Replacement

Non-Type-2 Diabetic and Non-Obese Controls

Experimental group

Description:

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

Treatment:

Procedure: Hip Replacement