Clinical Trial: Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Mayo Clinic

Current Primary Outcome: 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. [ Time Frame: 24 months ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Mayo Clinic

Dates:
Date Received: October 20, 2016
Date Started: September 2016
Date Completion: September 2017
Last Updated: October 20, 2016
Last Verified: October 2016