Osteoarthritis of the KneeNCT03543800
PRP Treatment of Osteoarthritic Knee With a New Autologous Blood Product (CytoRich)
A study testing Cytorich PRP kit and PRP kit in people with Osteoarthritis of the Knee, run by Antnor at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- Cytorich PRP kit and PRP kit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 4 Feb 2015to 20 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Cytorich PRP kit, PRP kit
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytorich PRP kitDevice
Subjects randomized to the PRP treatment arm will receive PRP only without the anti-inflammatory component of ABP added
PRP kitDevice
PRP kit legally marketed in Canada for PRP
| Study group | Role | What they receive |
|---|---|---|
| ABP | Experimental | (test treatment) Receives: Device: Cytorich PRP kit |
| PRP | Active comparator | (active control) Receives: Device: PRP kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain score
Change in VAS pain score
Measured: Week 12 (Day 85) compared to baseline for ABP and PRP
Secondary outcomes (1)
WOMAC pain and function score
Change in WOMAC pain and function score
Measured: Week 12 (Day 85) compared to baseline for ABP and PRP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start4 Feb 2015
- Primary completion20 May 2019 (estimated)
- Study completion20 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antnor
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ira Brokhman, PhD, Study director, Galea Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543800
- Sponsor's protocol ID
- GA-777
- Status last verified
- May 2018
- First submitted
- 22 May 2018
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Platelet-Rich Plasma Treatment of Osteoarthritic Knee With a New Autologous Blood Product (CytoRich)
- ClinicalTrials.gov ID
- NCT03543800
- Acronym / sponsor ID
- GA-777
- Conditions
- Osteoarthritis of the Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- AntnorIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2015 (actual)
- Primary completion
- 20 May 2019 (estimated)
- Study completion
- 20 May 2019 (estimated)
- First posted
- 1 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABP | Experimental | Device: Cytorich PRP kit(test treatment) |
| PRP | Active comparator | Device: PRP kit(active control) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytorich PRP kitSubjects randomized to the PRP treatment arm will receive PRP only without the anti-inflammatory component of ABP added | Device | ABP |
| PRP kitPRP kit legally marketed in Canada for PRP | Device | PRP |
Primary outcome
VAS pain score
Time frame: Week 12 (Day 85) compared to baseline for ABP and PRP
Change in VAS pain score
1 secondary outcome
WOMAC pain and function score
Time frame: Week 12 (Day 85) compared to baseline for ABP and PRP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Osteoarthritis of the Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira Brokhman, PhD study director
Galea Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytorich PRP kit and PRP kit in people with Osteoarthritis of the Knee, run by Antnor at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS pain score (time frame: Week 12 (Day 85) compared to baseline for ABP and PRP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.