Platelet-Rich Plasma Injections for Osteoarthritis

Overseen By Steven Phillips, MSc

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: ArthroBiologix Inc.

Disqualifiers: Inflammatory osteoarthritis, Open wounds, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether observing the preparation steps for platelet-rich plasma (PRP) injections can enhance treatment effectiveness for knee osteoarthritis. PRP uses a portion of the patient's own blood to aid healing. Participants will either watch the PRP preparation or not see it. This study may suit individuals diagnosed with knee osteoarthritis who experience symptoms. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for platelet-rich plasma (PRP) therapy?

Research shows that platelet-rich plasma (PRP) injections are generally safe for treating knee osteoarthritis. Studies have found that PRP can significantly reduce pain over six months. In these studies, patients reported better results with PRP compared to treatments like hyaluronic acid, a gel-like fluid injected into the joint.

Animal studies also support the safety of PRP. They indicate that PRP injections can decrease inflammation and reduce cartilage damage, suggesting that PRP is effective and well-tolerated by the body.

Since this trial is in a later phase, PRP has likely been tested in many people and found to be safe. While no treatment is without risk, PRP has shown a good safety record in the research conducted so far. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard osteoarthritis treatments that often rely on painkillers or invasive surgeries, platelet-rich plasma (PRP) injections utilize a patient's own blood to potentially speed up healing and reduce inflammation. PRP is unique because it involves concentrating platelets, which are rich in growth factors, and injecting them directly into the affected joint. This process not only targets the root cause of pain but also promotes tissue repair, offering a more natural and potentially longer-lasting solution. Researchers are excited about PRP because it represents a shift towards regenerative medicine, aiming to restore joint function rather than just manage symptoms.

What evidence suggests that platelet-rich plasma injections might be an effective treatment for osteoarthritis?

Research has shown that platelet-rich plasma (PRP) injections can reduce pain and improve movement in people with knee osteoarthritis. In this trial, participants will either view the preparation of the PRP or remain unaware of it. Studies have found that PRP significantly lowers pain levels; one study reported a decrease from 53.5 to 35.8 on a pain scale over six months. Many patients experience pain relief for 6 to 12 months, with about 60% to 70% achieving success. Compared to other treatments like hyaluronic acid (HA), PRP has delivered better results according to patients. Overall, PRP is considered an effective treatment option for knee osteoarthritis. ^{2 5 6 7 8}

Who Is on the Research Team?

Moin Khan, FRCSC

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

This trial is for men and women aged 50-80 with knee osteoarthritis, diagnosed through clinical exams and X-rays. Participants must be able to give informed consent. Details on who can't join are not provided.

Inclusion Criteria

I am between 50 and 80 years old.

I have been diagnosed with knee osteoarthritis that causes symptoms.

Provision of informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-articular platelet-rich plasma (PRP) injections for knee osteoarthritis, with or without observation of the preparatory steps

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain, function, and range of motion

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Platelet-rich plasma (PRP)
• Viewing of preparation

Trial Overview The study tests if watching the preparation of platelet-rich plasma (PRP) injections affects their effectiveness in treating knee osteoarthritis compared to those who don't watch the prep process.

How Is the Trial Designed?

Group I: Viewing of preparation Experimental Treatment 2 Interventions

The patient will be in the room for the preparation of the PRP and will receive a description of the centrifuge process from the physician administering the injection.

Group II: Blinded to preparation Placebo Group 1 Intervention

The patient will leave the room after their blood is drawn and will not view the preparation of the PRP, and will also not receive a description of the centrifuge process.

Platelet-rich plasma (PRP) is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Platelet-rich plasma for:

• Orthopedic conditions
• Wound care
• Dermatological conditions
• Hair restoration

Approved in Canada as Platelet-rich plasma for:

• Orthopedic conditions
• Wound care
• Dermatological conditions

Approved in European Union as Platelet-rich plasma for:

• Orthopedic conditions
• Wound care
• Dermatological conditions

Who Is Running the Clinical Trial?

ArthroBiologix Inc.

Lead Sponsor

Trials

2

Recruited

260+

Published Research Related to This Trial

PTP-001, a novel placental tissue particulate, contains significantly higher levels of key growth factors compared to both leukocyte-rich and leukocyte-poor platelet-rich plasma (PRP), suggesting a potentially more effective treatment for knee osteoarthritis.

Both PTP-001 and PRP can reduce inflammation in cell cultures, but PTP-001 shows more consistent results and greater efficacy in reducing harmful gene expressions related to cartilage degradation, indicating its superior therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Composition and Bioactivity of a Placental Tissue Particulate (PTP-001) Indicate Greater Potential than Platelet-Rich Plasma for the Treatment of Osteoarthritis. Flannery, CR., Buddin, KE., Begum, L., et al.[2023]

Autologous platelet-rich plasma (PRP) shows promise in reducing pain from osteoarthritis and may aid in cartilage repair, highlighting its potential therapeutic benefits.

PRP is derived from the patient's own blood and contains a variety of growth factors, but the commercial versions available can vary significantly in composition, which may affect their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial commentary: autologous platelet-rich plasma. Lubowitz, JH.[2018]

In a study involving 20 patients with knee osteoarthritis, treatment with autologous platelet-rich plasma (PRP) led to significant improvements in knee function and reduced pain levels over a 1-month follow-up period.

Patients also reported a decreased need for pain medications, suggesting that PRP injections could be an effective management strategy for knee OA in rural settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Platelet-Rich Plasma in the Management of Knee Osteoarthritis in a Rural Clinic. Mogoi, V., Elder, B., Hayes, K., et al.[2022]

Platelet-rich plasma (PRP) injections provide significant pain relief and functional improvement for knee osteoarthritis (OA) at 12 months post-injection, outperforming both hyaluronic acid (HA) and saline treatments.

PRP injections do not increase the risk of adverse events compared to HA and saline, indicating that they are a safe option for treating knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Dai, WL., Zhou, AG., Zhang, H., et al.[2022]

Intra-articular injections of platelet-rich plasma (PRP) significantly improve pain relief and function in patients with osteoarthritis (OA) across short, medium, and long-term periods, based on a systematic review of 30 randomized controlled trials.

The efficacy of PRP treatment appears to be influenced by factors such as trial size and gender composition, indicating that larger, high-quality studies that consider these variables are needed for a clearer understanding of PRP's therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of sample size and gender composition on the meta-analysis conclusion of platelet-rich plasma treatment for osteoarthritis. Zhao, K., Liu, YS., Nie, LY., et al.[2022]

Intra-articular injections of platelet-rich plasma (PRP) demonstrated disease-modifying effects in 68% of the 44 animal studies reviewed, showing potential to slow cartilage damage and reduce inflammation in osteoarthritis (OA).

Despite promising results, the studies had varying quality, with only 40% assessed as low risk of bias, indicating a need for further research to confirm these findings and explore optimal PRP formulations and treatment protocols before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma injections induce disease-modifying effects in the treatment of osteoarthritis in animal models. Boffa, A., Salerno, M., Merli, G., et al.[2021]

In a preliminary study of 14 patients with knee osteoarthritis, intraarticular platelet-rich plasma (PRP) injections showed significant improvements in pain and function, with no reported adverse events, indicating a favorable safety profile.

Patients experienced almost linear improvements in their Knee Injury and Osteoarthritis Outcome Scores over 12 months, suggesting that PRP may effectively relieve symptoms of osteoarthritis and warrant further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. Sampson, S., Reed, M., Silvers, H., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10333515/

Efficacy and safety of platelet-rich plasma injections for the ... However, PRP injection therapy did not significantly reduce pain symptoms in patients with HOA. In addition, the analgesic effect of LP-PRP was ...

2. sportsmed.org sportsmed.org/membership/sports-medicine-update/spring-2024/platelet-rich-plasma-for-osteoarthritis-in-2024

Platelet-Rich Plasma for Osteoarthritis in 2024 – More Hype A statistically significant improvement in patient-reported outcome scores was demonstrated with PRP over HA, while LP-PRP was associated with significantly ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40022138/

Comparative efficacy of different doses of platelet-rich ... The outcomes were reduction in the Visual Analogue Scale (VAS) pain score or improvement of the total Western Ontario and McMaster Universities ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352320425000781

Platelet-rich plasma therapy for knee osteoarthritis PRP therapy significantly improved the VAS scores from 53.5 at baseline to 35.8 at 6 months (P < 0.05). Patients with Kellgren-Lawrence (KL) grade 4 showed less ...

5. mayoclinic.org mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/analyzing-the-performance-of-platelet-rich-plasma-and-bone-marrow-aspirate-concentrate-injections-for-the-treatment-of-knee-osteoarthritis/mqc-20578651

Analyzing the performance of platelet-rich plasma and ... Many of our patients with knee OA report from 6 to 12 months of pain relief after treatment with PRP. We usually see a 60% to 70% chance of success.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40487921/

Platelet-rich plasma therapy for knee osteoarthritis: Insights ... PRP therapy significantly improved the VAS scores from 53.5 at baseline to 35.8 at 6 months (P < 0.05). Patients with Kellgren-Lawrence (KL) ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11992392/

Optimal frequency of platelet-rich plasma injections for ... Patients with KL grades 1 and 2 exhibited maximum pain relief after the fourth injection; those with KL grades 3 and 4 showed optimal results after the fifth ...

8. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-03253-4

Efficacy and safety of platelet-rich plasma injections for the ... Animal studies have further confirmed that intra-articular PRP injection can reduce inflammation levels, alleviate cartilage damage, and ...