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Clinical Trials/NCT02941666
NCT02941666
Terminated
Not Applicable

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

Mayo Clinic1 site in 1 country20 target enrollmentSeptember 2016
ConditionsOsteonecrosis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteonecrosis
Sponsor
Mayo Clinic
Enrollment
20
Locations
1
Primary Endpoint
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.
Status
Terminated
Last Updated
3 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
May 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rafael J. Sierra, M.D.

Professor of Orthopedics

Mayo Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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