Stem Cell Isolation From Femoral Heads Post Total Hip Arthroplasty

NCT ID: NCT06775600

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-08-01

Brief Summary

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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

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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.

Conditions

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Obesity and Type 2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Type-2 Diabetes

Cells are harvested from individuals with Type-2 Diabetes

Group Type EXPERIMENTAL

Hip Replacement

Intervention Type PROCEDURE

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

Obesity

Cells are Harvested from individuals with obesity

Group Type EXPERIMENTAL

Hip Replacement

Intervention Type 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

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

Group Type EXPERIMENTAL

Hip Replacement

Intervention Type PROCEDURE

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

Interventions

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Hip Replacement

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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David Hess

OTHER

Sponsor Role lead

Responsible Party

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David Hess

Dr. David Hess

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David A Hess, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University

Central Contacts

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David A Hess, PhD

Role: CONTACT

519.931.5777 ext. 24118

Caleb J Podgers

Role: CONTACT

343-364-4014

Other Identifiers

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125884

Identifier Type: -

Identifier Source: org_study_id

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