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Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip

NCT ID: NCT02941666

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2022-05-31

Brief Summary

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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

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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.

Conditions

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Osteonecrosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Collapse ON group

This group will consist of patients who have concentrations of Mesenchymal Stem Cells in with post collapse osteonecrosis.

No interventions assigned to this group

Pre-collapse group

This group will consist of patients who have concentrations of Mesenchymal Stem Cells in with pre-collapse osteonecrosis.

No interventions assigned to this group

FAI group

This control group will be selected in patients undergoing hip arthroscopy for femoral/acetabular impingement.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Rafael J. Sierra, M.D.

Professor of Orthopedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raphael J. Sierra, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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16-002241

Identifier Type: -

Identifier Source: org_study_id