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Knee OsteoarthritisEarly Phase 1NCT02468492

Pilot Synovial Fluid Molecular/Stem Cell Response to PRP in Knee Osteoarthritis: Clinical & Imaging Outcome Correlation

A Early Phase 1 study testing Platelet Rich Plasma and Normal Saline in people with Knee Osteoarthritis, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the affect that platelet rich plasma has on the molecular an cellular functioning of the knee joint. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Knee Osteoarthritis
What is being tested?
Platelet Rich Plasma and Normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Sep 2014to Nov 2015
Phase
Early Phase 1
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Early/Mild to Moderate Stage knee osteoarthritis (KOA), as determined by Kellgren-Lawrence Grade 2 to 3 on PA standing radiograph within the past three months;
  • A prospective subject who has a diagnosis of non-end stage KOA (i.e., a potential study candidate) and expresses interest in participating but has no XRAY within the specified time-period will be sent for a fresh XRAY. This XRAY will be read by a radiologist \& be paid for by the study.
  • >=40 years of age;
  • Average 100-point VAS score of >50, on average, within the past 3 months*, with KOA felt to be the primary contributor to pain.
  • Alternate 10-point scales with pain scores averaging >5 may be considered if the prospective subject also completes a VAS with score >50 at screening.
  • Exam consistent with KOA being primary etiology of pain;
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  • No signs of inflammatory arthropathy in medical record, history or physical examination;
  • A >3 millimeter intra-articular (IA) effusion present on ultrasound evaluation.
  • [If a chronic liver or renal disease patient, evidence of stable disease over/within the past six months, else exclusion.]
  • Veteran receiving care at McGuire VAMC.

Who cannot join

  • Morbid obesity (BMI >40);
  • Poorly controlled diabetes (hemoglobin A1C > 7.5 or fasting blood glucose of >200) in last 6 months;
  • Ipsilateral knee surgery, trauma within last 6 months, or corticosteroid injection within 3 months.
  • 4. History of inflammatory arthropathy (RA, SLE or crystalline arthritis of the knee)**;
  • Any rheumatoid arthritis or gout diagnosis is exclusionary.
  • Current infection of the affected joint or any other uncontrolled or untreated active infection.
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  • Moderate to severe anemia (hemoglobin < 11 g/dl) or thrombocytopenia (platelet count < 100,000); Hemoglobin >17 g/dl or <11 g/dl and/or platelet counts >500,000 or <100,000 platelets/μl.
  • [CBC obtained within 6 months will be required, even if obtained at initial screening visit.]
  • Individuals on dialysis, with liver failure, or uncontrolled renal or liver disease are excluded.
  • In those with chronic renal or liver disease, documentation of stable disease within the most recent 6 months will be required.
  • Individuals on a therapeutic anticoagulant (e.g., Warfarin, Dabigatran, Enoxaparin) and those with a history of coagulopathy are excluded.
  • Per standard clinical practice, subjects on anti-platelet therapy are not excluded.
  • Pregnancy or breast-feeding;
  • Female subjects of child-bearing potential must have a negative pregnancy screen prior to enrollment.
  • Female subjects of child-bearing potential must confirm they are not actively breast-feeding prior to enrollment.
  • Current illicit drug abuse / active alcohol abuse (i.e, Current substance abuse);
  • Uncontrolled psychiatric disorder;
  • Lack of transportation (i.e., to get to/from appointments at VAMC) and/or willingness to attend study appointments (screening/consent, Intervention, Day10-follow-up, Month-6 follow-up, and then visits over-the-phone / in-person / or via Telehealth for Month-3 and Month-12;
  • Advanced or currently active cancer.
  • Blood disorders (such as Sickle Cell Anemia, TTP, others)
  • Vulnerable populations: Individuals incapable of making informed decisions will not be enrolled, nor will those under some form of incarceration.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23224

Other trials in United States

About this study

Official title: Synovial Fluid Biomarker and Mesenchymal Stem Cell Response to PRP in Knee Osteoarthritis With Clinical and Imaging Outcome Correlation: Proof of Concept Study

The purpose of this study is to evaluate the affect that platelet rich plasma has on the molecular an cellular functioning of the knee joint.

Read the detailed description

In this study 18 subjects with mild to moderate symptomatic knee osteoarthritis will be recruited per an IRB approved protocol with explicit inclusion and exclusion criteria. Subjects who are enrolled and meet all criteria will be blinded and randomized (2:1) to receive Platelet Rich Plasma or normal saline "control". Prior to the intervention, a synovial fluid aspiration will occur. At follow up number one (approximately 10 days from baseline) a repeat aspiration will occur and a differential analysis of the molecular and biochemical effects will be undertaken; this data will serve as the primary outcome measures. This data will be correlated to clinical and imaging outcome measures which will be secondary outcome measures completed at baseline and intermittently throughout the study. The duration of the study is one year.

Being tested
Platelet Rich Plasma, Normal Saline
Keywords
Knee Osteoarthritis, Platelet Rich Plasma, Mechanism of Action, Stem Cells, Synovial Fluid
Medical subject headings
Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Platelet Rich PlasmaBiological

    Also called Platelet Concentrate

    Platelet rich plasma injection into knee versus placebo (saline) injection.

  • Normal SalineOther

    Platelet rich plasma injection into knee versus placebo (saline) injection.

Study groups in NCT02468492
Study groupRoleWhat they receive
Platelet Rich PlasmaExperimentalApproximately 5mL of intraarticular PRP once at baseline
Receives: Biological: Platelet Rich Plasma
Normal SalineOtherApproximately 5mL of intraarticular normal saline once at baseline
Receives: Other: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical Molecular Outcomes

    Evaluate for change in biochemical molecular milieu temporal response after PRP injection or normal saline (control) compared to baseline, as measured by multiplex suspension array technology.

    Measured: Baseline and 10 day follow up

Secondary outcomes (2)

  1. Clinical Outcomes

    Evaluation for change in pain level via VAS and WOMAC at baseline and follow up.

    Measured: 1 year

  2. Imaging Outcomes

    Evaluation for change in joint space width using knee radiographs at baseline and 6 month follow up.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2015 (estimated)
  2. Study startSep 2014
  3. Primary completionNov 2015
  4. Study completionNov 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02468492
Sponsor's protocol ID
IRB #01979/FDA IDE#15944
Status last verified
Aug 2017
First submitted
31 May 2015
Last updated
16 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided: Publications planned.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Platelet Rich Plasma and Normal Saline in people with Knee Osteoarthritis, run by Hunter Holmes Mcguire Veteran Affairs Medical Center 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 10 inclusion and 21 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: finished, as of the sponsor's last update on 16 Aug 2017. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Biochemical Molecular Outcomes (time frame: Baseline and 10 day follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02468492.

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 16 Aug 2017.

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Clinical Trial NCT02468492 | AzTrials