Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip

Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip in Patients With Osteonecrosis of the Femoral Head

Previous studies have shown an increase in the concentration of mesenchymal stem cells (MSC's) in the setting of osteoarthritis of the knee and its correlation to severity. Researchers have shown that as there is an increase in the severity of the disease, the concentration of stem cells also increases. The purpose of this study is to determine if there is the same increase in stem cell concentration in patients with osteonecrosis (ON) of the femoral head.

Study Overview

• Status: Terminated
• Conditions: Osteonecrosis

Detailed Description

Since the treatment of osteonecrosis is related to the severity of disease, namely articular cartilage collapse, the purpose of this study is to determine if the MSC concentration in synovial fluid can be correlated to disease stage. In order to do this the investigators will:

Milestone #1:

Determine the concentration of MSC's in the synovial fluid in patients with osteonecrosis. This work will be carried out utilizing FACS-based technique to synovial fluid stem cell sub-population.

Milestone #2:

Compare concentrations of MSC's in patients with pre collapse, post collapse osteonecrosis and "normal" hips. Patient-derived MSC will be quantified at the different stages of disease and assays will be performed in order to assess their viability. A control group will be selected in patients undergoing hip arthroscopy for femoral/acetabular impingement (FAI). Since FAI does not affect the intraarticular environment of the hip, theoretically these patients would have a "normal" concentration of synovial stem cells.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be identified in clinic as scheduled for total hip arthroplasty, hip arthroscopy or minimally invasive core decompression of the femoral head after granting consent.

Description

Inclusion Criteria:

• Patients consented to undergo a THA (post-collapse osteonecrosis), hip arthroscopy or minimally invasive core decompression
• Preoperative radiographic diagnosis of ON or FAI (femoral/acetabular impingement)

Exclusion Criteria:

• Pregnant females
• Active infection, HIV, Hepatitis C or B, syphilis Immunodeficiency
• Patients receiving hematopoetic growth factors or anti-angiogenesis products

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Collapse ON group; This group will consist of patients who have concentrations of Mesenchymal Stem Cells in with post collapse osteonecrosis.
Pre-collapse group; This group will consist of patients who have concentrations of Mesenchymal Stem Cells in with pre-collapse osteonecrosis.
FAI group; This control group will be selected in patients undergoing hip arthroscopy for femoral/acetabular impingement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The quantity of mesenchymal stem cells present in the synovial fluid of patients with precollapse ON of the femoral head and postcollapse ON of the femoral head compared to patients without intraarticular hip pathology.	Previous studies have shown an increase in the concentration of MSCs in the setting of osteoarthritis of the knee and its correlation to severity. Researchers have shown that as there is an increase in the severity of the disease, the concentration of stem cells also increases. The purpose of this study is to determine if there is the same increase in stem cell concentration in patients with osteonecrosis (ON) of the femoral head. Since the treatment of osteonecrosis is related to the severity of disease, namely articular cartilage collapse, the purpose of this study is to determine if the MSC concentration in synovial fluid can be correlated to disease stage.	24 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Raphael J. Sierra, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: October 20, 2016
• First Submitted That Met QC Criteria: October 20, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Musculoskeletal Diseases; Bone Diseases; Osteonecrosis
• Other Study ID Numbers: 16-002241

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided