Clinical trial NCT02941666: Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip
Official title: Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip in Patients With Osteonecrosis of the Femoral Head
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Osteonecrosis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: 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.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Raphael J. Sierra, M.D.
role: PRINCIPAL_INVESTIGATOR
References: