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

NCT ID: NCT03543800

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-04
• Study Completion Date: 2019-05-20

Brief Summary

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.

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).

Conditions

Osteoarthritis of the Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

ABP

(test treatment)

Group Type: EXPERIMENTAL

Cytorich PRP kit

Intervention Type: DEVICE

Subjects randomized to the PRP treatment arm will receive PRP only without the anti-inflammatory component of ABP added

PRP

(active control)

Group Type: ACTIVE_COMPARATOR

PRP kit

Intervention Type: DEVICE

PRP kit legally marketed in Canada for PRP

Interventions

Cytorich PRP kit

Subjects randomized to the PRP treatment arm will receive PRP only without the anti-inflammatory component of ABP added

Intervention Type: DEVICE

PRP kit

PRP kit legally marketed in Canada for PRP

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Antnor

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ira Brokhman, PhD

Role: STUDY_DIRECTOR

Galea Clinic

Locations

Galea Clinic

Etobicoke, Ontario, Canada

Countries

Canada

Other Identifiers

GA-777

Identifier Type: -

Identifier Source: org_study_id