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

NCT03543800 | Unknown

• 1 other identifier: GA-777
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• VAS pain score

  Change in VAS pain score

  Week 12 (Day 85) compared to baseline for ABP and PRP

Secondary Outcomes (1)

• WOMAC pain and function score

  Week 12 (Day 85) compared to baseline for ABP and PRP

Study Arms (2)

ABP

EXPERIMENTAL

(test treatment)

Device: Cytorich PRP kit

PRP

ACTIVE COMPARATOR

(active control)

Device: PRP kit

Interventions

Cytorich PRP kit DEVICE

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

ABP

PRP kit DEVICE

PRP kit legally marketed in Canada for PRP

PRP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antnor: lead

Study Sites (1)

Galea Clinic

Etobicoke, Ontario, M8W 3T4, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Ira Brokhman, PhD

  Galea Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 1, 2018
• Study Start: February 4, 2015
• Primary Completion: May 20, 2019
• Study Completion: May 20, 2019
• Last Updated: June 1, 2018

Record last verified: 2018-05

Locations

CA (1)