OsteonecrosisNCT02941666
Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip
An observational study of Osteonecrosis, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteonecrosis
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Pregnant females
- Active infection, HIV, Hepatitis C or B, syphilis Immunodeficiency
- Patients receiving hematopoetic growth factors or anti-angiogenesis products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip in Patients With Osteonecrosis of the Femoral Head
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.
Read the 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.
- Conditions
- Osteonecrosis
- Medical subject headings
- Osteonecrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Collapse ON group | This group will consist of patients who have concentrations of Mesenchymal Stem Cells in with post collapse osteonecrosis. | |
| Pre-collapse group | This group will consist of patients who have concentrations of Mesenchymal Stem Cells in with pre-collapse osteonecrosis. | |
| FAI group | This control group will be selected in patients undergoing hip arthroscopy for femoral/acetabular impingement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionMay 2022
- Study completionMay 2022
Why it stopped: Study staff was unable to collect proper samples to meet study goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteonecrosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael J. Sierra, M.D., Mayo Clinic
- Investigators
- Raphael J. Sierra, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941666
- Sponsor's protocol ID
- 16-002241
- Status last verified
- Dec 2022
- First submitted
- 20 Oct 2016
- Last updated
- 12 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Mesenchymal Stem Cells in the Synovial Fluid of the Hip in Patients With Osteonecrosis of the Femoral Head
- ClinicalTrials.gov ID
- NCT02941666
- Acronym / sponsor ID
- 16-002241
- Conditions
- Osteonecrosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study staff was unable to collect proper samples to meet study goals
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 21 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Collapse ON group | – | –This group will consist of patients who have concentrations of Mesenchymal Stem Cells in with post collapse osteonecrosis. |
| Pre-collapse group | – | –This group will consist of patients who have concentrations of Mesenchymal Stem Cells in with pre-collapse osteonecrosis. |
| FAI group | – | –This control group will be selected in patients undergoing hip arthroscopy for femoral/acetabular impingement. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (3 listed)
- Pregnant females
- Active infection, HIV, Hepatitis C or B, syphilis Immunodeficiency
- Patients receiving hematopoetic growth factors or anti-angiogenesis products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
Results and safety
The study was stopped early (reason given: Study staff was unable to collect proper samples to meet study goals). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael J. Sierra, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteonecrosis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study staff was unable to collect proper samples to meet study goals). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2022.