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Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip

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Mayo Clinic

Status

Terminated

Conditions

Osteonecrosis

Study type

Observational

Funder types

Other

Identifiers

NCT02941666
16-002241

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

20 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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