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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03543800
• Other study ID #: GA-777
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 4, 2015
• Est. completion date: May 20, 2019

Study information

• Verified date: May 2018
• Source: Antnor
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 20, 2019
• Est. primary completion date: May 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Device:
• Cytorich PRP kit
Subjects randomized to the PRP treatment arm will receive PRP only without the anti-inflammatory component of ABP added
• PRP kit
PRP kit legally marketed in Canada for PRP

Locations

Country	Name	City	State
Canada	Galea Clinic	Etobicoke	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Antnor

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS pain score	Change in VAS pain score	Week 12 (Day 85) compared to baseline for ABP and PRP
Secondary	WOMAC pain and function score	Change in WOMAC pain and function score	Week 12 (Day 85) compared to baseline for ABP and PRP