Osteoarthritis, KneeNCT02370823
A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment
An observational study of Osteoarthritis, Knee, run by Regenexx, LLC at 1 site in United States.
Trial summary
The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx® SD treatment. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Regenexx SD
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Mar 2018
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will have unilateral knee OA as evidenced with physical examination and MRI. Subjects will be recruited from the physician practice and will be males and females age 35-85.
Who may be able to join
- Voluntary signature of the IRB approved Informed Consent
- Unilateral osteoarthritic male or female ages 35-85
- Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in one knee joint
- Physical examination consistent with osteoarthritis in one knee joint
- Restricted range of motion of the affected knee (<135 degrees in flexion and/or >0 degrees of extension)
- Kellgren-Lawrence grade 2 or greater knee osteoarthritis with diagnostic MR imaging of the affected knee showing osteoarthritis
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- Limited knee effusion in osteoarthritic knee (i.e. not more than 20 ml of visible joint fluid on ultrasound examination of the knee.)
- Normal range of motion of the unaffected knee
- No sign of pain, swelling, and/or functional disability of the unaffected knee
- No history of acute injury in the unaffected knee
- Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Who cannot join
- Knee injections of any type within 6 months prior to the study.
- Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
- Quinolone or Statin induced myopathy/tendinopathy
- Symptomatic lumbar spine pathology (e.g. radicular pain)
- Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh (i.e. evidence of complex regional pain syndrome or central sensitization with allodynia present on exam).
- Contraindications for MRI
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- Tested positive or has been treated for a malignancy in the past five years or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed injection site
- Condition represents a worker's compensation case
- Currently involved in a health-related litigation procedure
- Is pregnant
- Bleeding disorders
- Currently taking anticoagulant or immunosuppressive medication
- Allergy or intolerance to study medication
- Use of chronic opioid
- Documented history of drug abuse within six months of treatment
- 18) Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx® SD treatment.
Read the detailed description
The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx SD treatment (day 0).
Secondary objective is an evaluation of possible direct and/or indirect associations between the measured levels of proteins and/or cellular components of the synovial fluid in the osteoarthritic knee joint with the administration of the Regenexx SD treatment. The secondary objective will include MRI evidence of cartilage repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Regenexx SD
- Keywords
- Osteoarthritis, Knee
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenexx SDProcedure or surgery
Also called Bone Marrow Concentrate
stem cell treatment
| Study group | Role | What they receive |
|---|---|---|
| Knee OA Treated with Regenexx SD | 20 subjects with unilateral knee osteoarthritis. Collection of synovial fluid from both knees will serve as the experimental condition, i.e. the osteoarthritic knee, and the matched control, i.e. the knee not demonstrating signs of osteoarthritis. Alterations in the concentration of the synovial fluid proteins and cellular components will be evaluated up to 6 weeks post-Regenexx® SD - Same Day Bone Marrow Concentrate Injection treatment. Receives: Procedure: Regenexx SD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median change in protein concentration or percentage of cellular subpopulations
A comparison of the patient temporal median change in protein concentration or percentage of cellular subpopulations from pre-injection to 6 weeks post- Regenexx SD treatment.
Measured: 6 weeks compared to baseline
Secondary outcomes (4)
Mean Change in Pain Scale from baseline to 6 weeks
Mean Numeric Pain Scale
Measured: 6 weeks
Mean Change in IKDC Scores from baseline to 6 weeks
Mean Patient Reported Pain and Function Scale
Measured: 6 weeks
Incidence and time to resolution of post-operative complications and adverse events
Incidence and time to resolution of post-operative complications and adverse events
Measured: 6 weeks
Incidence and time to re-injection/re-operation
Incidence and time to re-injection/re-operation
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2018
- Study completionMar 2018
Why it stopped: Terminated early for poor study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regenexx, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Centeno, MD, Principal investigator, Centeno-Schultz Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370823
- Sponsor's protocol ID
- RSI2014-LAB01
- Status last verified
- Mar 2018
- First submitted
- 10 Feb 2015
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Surveillance of the Osteoarthritic Knee Microenvironment With Regenexx® SD Treatment
- ClinicalTrials.gov ID
- NCT02370823
- Acronym / sponsor ID
- RSI2014-LAB01
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated early for poor study design.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Regenexx, LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 25 Feb 2015 (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.
The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx® SD treatment.
Detailed description
The primary objective of this study is to determine the levels of proteins and/or cellular components of the synovial fluid that are indicative of microenvironment phenotypes of the osteoarthritic knee compared to unilateral unaffected joints pre-injection to 6 weeks post-Regenexx SD treatment (day 0).
Secondary objective is an evaluation of possible direct and/or indirect associations between the measured levels of proteins and/or cellular components of the synovial fluid in the osteoarthritic knee joint with the administration of the Regenexx SD treatment. The secondary objective will include MRI evidence of cartilage repair; incidence of post-operative complications, adverse events, re-injections, and surgical intervention; change in pain score and use of pain medications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee OA Treated with Regenexx SD | – | Procedure: Regenexx SD20 subjects with unilateral knee osteoarthritis. Collection of synovial fluid from both knees will serve as the experimental condition, i.e. the osteoarthritic knee, and the matched control, i.e. the knee not demonstrating signs of osteoarthritis. Alterations in the concentration of the synovial fluid proteins and cellular components will be evaluated up to 6 weeks post-Regenexx® SD - Same Day Bone Marrow Concentrate Injection treatment. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will have unilateral knee OA as evidenced with physical examination and MRI. Subjects will be recruited from the physician practice and will be males and females age 35-85.
Key inclusion criteria (11 listed)
- Voluntary signature of the IRB approved Informed Consent
- Unilateral osteoarthritic male or female ages 35-85
- Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in one knee joint
- Physical examination consistent with osteoarthritis in one knee joint
- Restricted range of motion of the affected knee (<135 degrees in flexion and/or >0 degrees of extension)
Key exclusion criteria (16 listed)
- Knee injections of any type within 6 months prior to the study.
- Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
- Quinolone or Statin induced myopathy/tendinopathy
- Symptomatic lumbar spine pathology (e.g. radicular pain)
- Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh (i.e. evidence of complex regional pain syndrome or central sensitization with allodynia present on exam).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regenexx SDAlso: Bone Marrow Concentratestem cell treatment | Procedure or surgery | Knee OA Treated with Regenexx SD |
Primary outcome
Median change in protein concentration or percentage of cellular subpopulations
Time frame: 6 weeks compared to baseline
A comparison of the patient temporal median change in protein concentration or percentage of cellular subpopulations from pre-injection to 6 weeks post- Regenexx SD treatment.
4 secondary outcomes
Mean Change in Pain Scale from baseline to 6 weeks
Time frame: 6 weeks
Mean Change in IKDC Scores from baseline to 6 weeks
Time frame: 6 weeks
Incidence and time to resolution of post-operative complications and adverse events
Time frame: 6 weeks
Incidence and time to re-injection/re-operation
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Terminated early for poor study design.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Christopher Centeno, MD principal investigator
Centeno-Schultz 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 Osteoarthritis, Knee, run by Regenexx, LLC 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 11 inclusion and 16 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 30 Mar 2018. 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: Terminated early for poor study design.). 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?
Median change in protein concentration or percentage of cellular subpopulations (time frame: 6 weeks compared to baseline). 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 30 Mar 2018.