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

NCT02468492 | Completed Early Phase 1 FDA Device

• 1 other identifier: IRB #01979/FDA IDE#15944
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Platelet Rich Plasma; Mechanism of Action; Stem Cells; Synovial Fluid

Outcome Measures

Primary Outcomes (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.

  Baseline and 10 day follow up

Secondary Outcomes (2)

• Clinical Outcomes

  1 year

• Imaging Outcomes

  6 months

Study Arms (2)

Platelet Rich Plasma

EXPERIMENTAL

Approximately 5mL of intraarticular PRP once at baseline

Biological: Platelet Rich Plasma

Normal Saline

OTHER

Approximately 5mL of intraarticular normal saline once at baseline

Other: Normal Saline

Interventions

Platelet Rich Plasma BIOLOGICAL

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

Also known as: Platelet Concentrate

Platelet Rich Plasma

Normal Saline OTHER

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

Normal Saline

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• No signs of inflammatory arthropathy in medical record, history or physical examination;
• A \>3 millimeter intra-articular (IA) effusion present on ultrasound evaluation.
• Veteran receiving care at McGuire VAMC.

You may not qualify if:

• 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.
• \. History of inflammatory arthropathy (RA, SLE or crystalline arthritis of the knee)\*\*;
• Current infection of the affected joint or any other uncontrolled or untreated active infection.
• 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);

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead
• Foundation for Physical Medicine and Rehabilitation: collaborator

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23224, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Lance L Goetz, MD

  Hunter Holmes McGuire VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: May 31, 2015
• First Posted: June 10, 2015
• Study Start: September 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 16, 2017

Record last verified: 2017-08

Locations

US (1)