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

158 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine whether outcomes for patients receiving intra-articular platelet-rich plasma (PRP) injections for knee osteoarthritis are influenced by observation of the preparatory steps to the procedure. The viewing of the steps involved in the administration of PRP may increase the effectiveness of the treatment in comparison to patients who have not observed the preparatory steps.

Will I have to stop taking my current medications?

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

Is platelet-rich plasma (PRP) safe for humans?

Research on platelet-rich plasma (PRP) injections, including for osteoarthritis, suggests it is generally safe for humans, as it uses a person's own blood components, reducing the risk of adverse reactions. ^{1 2 3 4 5}

How is platelet-rich plasma treatment different from other osteoarthritis treatments?

Platelet-rich plasma (PRP) treatment is unique because it uses a patient's own blood to create a concentrated mix of platelets that release growth factors and anti-inflammatory signals, potentially promoting joint repair and reducing inflammation, unlike most treatments that only address symptoms. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment Platelet-rich plasma (PRP) for osteoarthritis?

Research suggests that PRP injections may help reduce pain and promote cartilage repair in osteoarthritis, as PRP contains growth factors and anti-inflammatory signals that can improve joint health. ^{2 3 5 6 7}

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

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 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]

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]

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]

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]

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]

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]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma injections induce disease-modifying effects in the treatment of osteoarthritis in animal models. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of Platelet-Rich Plasma in the Management of Knee Osteoarthritis in a Rural Clinic. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Singapore 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. [2022]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. [2022]