PRP Treatment of Osteoarthritic Knee With a New Autologous Blood Product (CytoRich)

Comparison of Conventional Platelet-Rich Plasma Treatment of Osteoarthritic Knee With a New Autologous Blood Product (CytoRich)

This study is aimed at evaluating the efficacy and safety of Cytorich compared to platelet-rich plasma (PRP) in alleviating pain and improving function in subjects with knee OA.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Device: Cytorich PRP kit; Device: PRP kit

Detailed Description

This active-controlled, randomized, double-blind, prospective study will enroll subjects with knee OA. Subjects will be randomized equally to treatment with 4 injections of ABP (test treatment) or 4 injections of PRP (active control).

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Etobicoke, Ontario, Canada, M8W 3T4
      • Galea Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Radiographic confirmation of OA in the knee and screening knee pain score of >50 mm on a 100 mm visual analog scale (VAS) for at least one knee.

Exclusion Criteria:

• Female who is pregnant, lactating, or unwilling to use adequate contraception during the clinical study.
• Subject who had viscosupplementation within 3 months of screening.
• Subject treated with non-steroidal anti-inflammatory drugs (NSAIDs) within 72 hours of screening.
• Subject who received steroid treatment within 8 weeks of screening.
• Subject who had an acute disease or trauma within 6 weeks of screening.
• Subject with any major surgery, arthoplasty or arthroscopy in the target knee or lower extremities within 6 weeks of screening (or any planned surgeries throughout the duration of the study).
• Subject with a major dysplasia or congenital abnormality of the knee or a condition which may affect the knee (i.e., osteonecrosis, chondrocalcinosis).
• Subject with a primary inflammatory arthropathy (i.e., rheumatoid arthritis, psoriatic arthritis, gouty arthritis).
• Subject with knee joint infection, skin diseases, or infections in or near the area of injection.
• Subject with any musculoskeletal condition that would impede measurement of the effectiveness at the knee (in particular symptomatic hip OA).
• Subject with any claudication or peripheral vascular disease.
• Subject with active malignancy or that has been in treatment for a malignancy within the past 3 years.
• Subject with uncontrolled diabetes mellitus, diabetic neuropathy, or complications from infection.
• Subject with known sensitivity to citric acid.
• Subject taking oral or parental anticoagulant therapy other than acetylsalicylic acid 325 mg per day or less.
• Subject with active disease that may require periodic treatment with systemic steroids during the study period.
• Subject with other diseases or conditions as assessed by the Investigator that may limit the ability to perform necessary study evaluations (e.g., active alcohol abuse, active drug abuse, significant psychiatric or neurological disorders, planned relocation, etc.) or any other factors (e.g., ongoing litigation for workers compensation for musculoskeletal injuries or disorders) that may compromise the subject's ability to participate in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABP; (test treatment)	Device: Cytorich PRP kit; Subjects randomized to the PRP treatment arm will receive PRP only without the anti-inflammatory component of ABP added
Active Comparator: PRP; (active control)	Device: PRP kit; PRP kit legally marketed in Canada for PRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS pain score	Change in VAS pain score	Week 12 (Day 85) compared to baseline for ABP and PRP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
WOMAC pain and function score	Change in WOMAC pain and function score	Week 12 (Day 85) compared to baseline for ABP and PRP

Collaborators and Investigators

• Sponsor: Antnor
• Investigators: Study Director: Ira Brokhman, PhD, Galea Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2015
• Primary Completion (Anticipated): May 20, 2019
• Study Completion (Anticipated): May 20, 2019

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 1, 2018

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 22, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: GA-777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No