Obesity and Type 2 DiabetesNCT06775600
Stem Cell Isolation From Femoral Heads Post Total Hip Arthroplasty
A study testing Hip Replacement in people with Obesity and Type 2 Diabetes, run by David Hess.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity and Type 2 Diabetes
- What is being tested?
- Hip Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be 18+ years of age
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
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.
Read the 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.
- Conditions
- Obesity and Type 2 Diabetes
- Being tested
- Hip Replacement
- Keywords
- Stem Cell, Diabetes, Obesity, Regeneration
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip ReplacementProcedure or surgery
Total Hip Arthroplasty where the Femoral Head will be used to harvest stem cells post-extrication from the individual.
| Study group | Role | What they receive |
|---|---|---|
| Type-2 Diabetes | Experimental | Cells are harvested from individuals with Type-2 Diabetes Receives: Procedure: Hip Replacement |
| Obesity | Experimental | Cells are Harvested from individuals with obesity Receives: Procedure: Hip Replacement |
| Non-Type-2 Diabetic and Non-Obese Controls | Experimental | Cells are harvested from individuals with no Type-2 Diabetes and no Obesity Receives: Procedure: Hip Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell Yield
Quantification of how many cells are harvested from each femoral head prior to expansion in vitro
Measured: 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.
Measured: 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.
Measured: Time of cell harvest to 8 weeks post harvest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Hess
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, David Hess, Western University, Canada
- Investigators
- David A Hess, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775600
- Sponsor's protocol ID
- 125884
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared, unless disseminated in study publication. This is to protect the study participants.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06775600
- Acronym / sponsor ID
- 125884
- Conditions
- Obesity and Type 2 Diabetes
- Keywords
- Stem Cell, Diabetes, Obesity, Regeneration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- David HessUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type-2 Diabetes | Experimental | Procedure: Hip ReplacementCells are harvested from individuals with Type-2 Diabetes |
| Obesity | Experimental | Procedure: Hip ReplacementCells are Harvested from individuals with obesity |
| Non-Type-2 Diabetic and Non-Obese Controls | Experimental | Procedure: Hip ReplacementCells are harvested from individuals with no Type-2 Diabetes and no Obesity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be 18+ years of age
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hip ReplacementTotal Hip Arthroplasty where the Femoral Head will be used to harvest stem cells post-extrication from the individual. | Procedure or surgery | Non-Type-2 Diabetic and Non-Obese Controls, Obesity, Type-2 Diabetes |
Primary outcome
Cell Yield
Time frame: Within 24 hours of surgery
Quantification of how many cells are harvested from each femoral head prior to expansion in vitro
Cellular Growth Kinetics
Time frame: Time of cell harvest to 8 weeks post harvest
Quantification of the Growth Kinetics of each cell type during in vitro cell culture post cell harvest.
Cellular Phenotype
Time frame: Time of cell harvest to 8 weeks post harvest
Analysis via flow cytometry of the phenotype of each cell type and their respective surface markers that are involved in regenerative pathways.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared, unless disseminated in study publication. This is to protect the study participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David A Hess, PhD principal investigator
Western University
Questions about this trial
What is this clinical trial studying?
A study testing Hip Replacement in people with Obesity and Type 2 Diabetes, run by David Hess.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David A Hess, PhD (519.931.5777 ext. 24118, dhess3@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell Yield (time frame: Within 24 hours of surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.