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

Primary Purpose

Osteoarthritis of the Knee

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Cytorich PRP kit

PRP kit

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Galea Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ABP

PRP

Arm Description

(test treatment)

(active control)

Outcomes

Primary Outcome Measures

VAS pain score

Change in VAS pain score

Secondary Outcome Measures

WOMAC pain and function score

Change in WOMAC pain and function score

Full Information

NCT ID

NCT03543800

First Posted

May 22, 2018

Last Updated

May 22, 2018

Sponsor

Antnor

1. Study Identification

Unique Protocol Identification Number

NCT03543800

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 4, 2015 (Actual)

Primary Completion Date

May 20, 2019 (Anticipated)

Study Completion Date

May 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Antnor

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis of the Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ABP

Arm Type

Experimental

Arm Description

(test treatment)

Arm Title

PRP

Arm Type

Active Comparator

Arm Description

(active control)

Intervention Type

Device

Intervention Name(s)

Cytorich PRP kit

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

PRP kit

Intervention Description

PRP kit legally marketed in Canada for PRP

Primary Outcome Measure Information:

Title

VAS pain score

Description

Change in VAS pain score

Time Frame

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

Secondary Outcome Measure Information:

Title

WOMAC pain and function score

Description

Change in WOMAC pain and function score

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ira Brokhman, PhD

Organizational Affiliation

Galea Clinic

Official's Role

Study Director

Facility Information:

Facility Name

Galea Clinic

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M8W 3T4

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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