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

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ClinicalTrials.gov Identifier: NCT02468492
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : August 16, 2017
Sponsor:
Collaborator:
Foundation for Physical Medicine and Rehabilitation
Information provided by (Responsible Party):
Dr. Lance Goetz, Hunter Holmes Mcguire Veteran Affairs Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: Platelet Rich Plasma Other: Normal Saline Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
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
Study Start Date : September 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Platelet Rich Plasma
Approximately 5mL of intraarticular PRP once at baseline
Biological: Platelet Rich Plasma
Platelet rich plasma injection into knee versus placebo (saline) injection.
Other Name: Platelet Concentrate

Normal Saline
Approximately 5mL of intraarticular normal saline once at baseline
Other: Normal Saline
Platelet rich plasma injection into knee versus placebo (saline) injection.




Primary Outcome Measures :
  1. Biochemical Molecular Outcomes [ Time Frame: Baseline and 10 day follow up ]
    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.


Secondary Outcome Measures :
  1. Clinical Outcomes [ Time Frame: 1 year ]
    Evaluation for change in pain level via VAS and WOMAC at baseline and follow up.

  2. Imaging Outcomes [ Time Frame: 6 months ]
    Evaluation for change in joint space width using knee radiographs at baseline and 6 month follow up.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. >=40 years of age;
  3. 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.
  4. Exam consistent with KOA being primary etiology of pain;
  5. No signs of inflammatory arthropathy in medical record, history or physical examination;
  6. A >3 millimeter intra-articular (IA) effusion present on ultrasound evaluation.
  7. [If a chronic liver or renal disease patient, evidence of stable disease over/within the past six months, else exclusion.]
  8. Veteran receiving care at McGuire VAMC.

Exclusion Criteria:

  1. Morbid obesity (BMI >40);
  2. Poorly controlled diabetes (hemoglobin A1C > 7.5 or fasting blood glucose of >200) in last 6 months;
  3. Ipsilateral knee surgery, trauma within last 6 months, or corticosteroid injection within 3 months.
  4. 4. History of inflammatory arthropathy (RA, SLE or crystalline arthritis of the knee)**;
  5. Any rheumatoid arthritis or gout diagnosis is exclusionary.
  6. Current infection of the affected joint or any other uncontrolled or untreated active infection.
  7. 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.]
  8. 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.
  9. 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.
  10. 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.
  11. Current illicit drug abuse / active alcohol abuse (i.e, Current substance abuse);
  12. Uncontrolled psychiatric disorder;
  13. 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;
  14. Advanced or currently active cancer.
  15. Blood disorders (such as Sickle Cell Anemia, TTP, others)
  16. Vulnerable populations: Individuals incapable of making informed decisions will not be enrolled, nor will those under some form of incarceration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468492


Locations
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United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23224
Sponsors and Collaborators
Hunter Holmes Mcguire Veteran Affairs Medical Center
Foundation for Physical Medicine and Rehabilitation
Investigators
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Principal Investigator: Lance L Goetz, MD Hunter Holmes McGuire VAMC

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Responsible Party: Dr. Lance Goetz, Staff Physician, Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02468492     History of Changes
Other Study ID Numbers: IRB #01979/FDA IDE#15944
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Publications planned.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by Dr. Lance Goetz, Hunter Holmes Mcguire Veteran Affairs Medical Center:
Knee Osteoarthritis
Platelet Rich Plasma
Mechanism of Action
Stem Cells
Synovial Fluid
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases