PRP Injections for Osteoarthritis

(PRP-KOBE Trial)

Overseen By Anthony Luke, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of California, San Francisco

Must not be taking: Chemotherapy, Prednisone, Anti-inflammatories

Disqualifiers: Knee surgery, Rheumatologic disease, Cancer, others

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

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how platelet-rich plasma (PRP) injections can aid individuals with knee osteoarthritis by examining changes in blood proteins. Participants will receive either a PRP injection or a placebo (saltwater solution) to determine which more effectively reduces symptoms. Those initially receiving the placebo can switch to PRP later in the trial. Individuals who have experienced knee osteoarthritis symptoms for at least three months and can attend physical therapy may be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those taking chemotherapy, regular prednisone, or anti-inflammatory medications. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that PRP injections are likely to be safe for humans?

Research shows that platelet-rich plasma (PRP) injections are generally safe for treating osteoarthritis (OA). Studies have found that PRP can improve joint movement and reduce pain without major side effects. For example, one study found that PRP injections relieved pain and improved hand function in people with thumb arthritis, without significant complications. Another study showed that PRP is safe and effective for managing hip arthritis.

These findings suggest that PRP is well-tolerated, with no major safety concerns reported in the reviewed studies. Prospective participants in a clinical trial involving PRP injections might find this information reassuring regarding the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Platelet-Rich Plasma (PRP) injections are unique because they use components derived from the patient's own blood to potentially treat osteoarthritis. Unlike traditional treatments like NSAIDs or corticosteroid injections, PRP harnesses the body's natural healing factors, concentrating platelets that release growth factors to aid in tissue repair. Researchers are excited about PRP because it offers a personalized approach with a novel mechanism of action that may alleviate symptoms and improve joint function without the side effects associated with more conventional therapies. Additionally, the potential for PRP to promote long-term healing rather than just temporary relief sets it apart from current options.

What evidence suggests that PRP injections might be an effective treatment for osteoarthritis?

Research has shown that platelet-rich plasma (PRP) injections, which participants in this trial may receive, can help treat knee osteoarthritis. Studies have found that many patients experience pain relief for 6 to 12 months after receiving PRP injections, with a 60% to 70% chance of success. In one study, patients reported significantly less pain and improved movement compared to other treatments. Another study confirmed that a single PRP injection could lead to long-lasting pain relief and improved knee function. These findings suggest that PRP might be a promising option for people with knee osteoarthritis. ^{4 6 7 8 9}

Who Is on the Research Team?

Anthony Luke, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-70 with knee osteoarthritis, seeking treatment at a University Based sports medicine clinic. Participants will be divided into two age groups and must meet all qualifying requirements to join.

Inclusion Criteria

My knee has been graded between 1 to 3 for arthritis severity.

My osteoarthritis pain is only in one joint and does not affect my hips, ankles, or the other knee.

Will be able to attend and perform physical therapy

Exclusion Criteria

I have a condition that affects my blood's ability to clot.

I have had septic arthritis in the past.

I have had knee injection therapy for osteoarthritis in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive either a PRP injection or a normal saline injection, with an option to cross over to PRP at week 12

12 weeks

3 visits (in-person)

Crossover

Participants in the control group may receive a PRP injection at week 12

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

3 visits (1 in-person, 2 virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Platelet-Rich Plasma (PRP) Injections

Trial Overview The study tests the effects of Platelet-Rich Plasma (PRP) injections versus saline injections in treating knee osteoarthritis. It's randomized and double-blind, meaning neither the researchers nor participants know who gets PRP or placebo until after the study.

How Is the Trial Designed?

Group I: Platelet-rich plasma (PRP) Experimental Treatment 2 Interventions

A vacutainer vial containing 50 mL of peripheral blood will be processed immediately to create PRP using a previously optimized two-step centrifugation protocol viii. First, the whole blood will be centrifuged at 500 x g for 8 minutes at 4°C. The plasma will be collected above the buffy coat using a sterile pipette, placed into a separate sterile tube, and centrifuged a second time at 700 x g for 17 minutes at 12° C. The top 70% will be collected as the PPP and the bottom 30% will be resuspended as the PRP. PPP will be aliquoted into cryovials for storage at -80 °C. Approximately 6 mL of PRP will be produced from each 50 mL vial of whole blood. Five mL will be allocated for administration to patients and the remaining one mL will be aliquoted into cryovials for storage at -80 °C. The syringe containing PRP will be covered with Aluminum foil, such that the investigator cannot tell what fluid is to be injected.

Group II: Control saline injection (wait-list control) Placebo Group 3 Interventions

A placebo injection of 6 mL of 0.9% saline will be prepared by the unblinded research assistant in an adjacent room. The syringed will be prepared in a 10 mL syringe and covered with Aluminum foil, such that the investigator performing the injection cannot tell if there is PRP or saline to be injected.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

Intra-articular platelet-rich plasma (PRP) injections significantly relieve pain in knee osteoarthritis compared to saline and corticosteroid injections, with a large effect size indicating clinical importance.

There was no significant difference in effectiveness between leukocyte-poor PRP (LP-PRP) and leukocyte-rich PRP (LR-PRP), suggesting both types may be similarly beneficial, but further high-quality studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Clinical Trials. Nie, LY., Zhao, K., Ruan, J., et al.[2022]

A systematic review of 5 randomized controlled trials involving 301 patients found that a single injection of platelet-rich plasma (PRP) is as effective as multiple injections for reducing pain in knee osteoarthritis over a 6-month period.

However, multiple PRP injections showed a significant improvement in knee functionality compared to a single injection, particularly when comparing single versus triple injections, indicating that while pain relief may be similar, functionality benefits from more frequent treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Clinical Effectiveness of Single Versus Multiple Injections of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Systematic Review and Meta-analysis. Vilchez-Cavazos, F., Millán-Alanís, JM., Blázquez-Saldaña, J., et al.[2022]

Intra-articular injections of platelet-rich plasma (PRP) are considered an effective symptomatic treatment for early to moderate knee osteoarthritis, supported by strong expert agreement and a high level of evidence (1A).

A recommended treatment sequence includes 1-3 PRP injections, and leucocyte-poor PRP is preferred for better outcomes, although many recommendations are based on expert opinion rather than high-level evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular injections of platelet-rich plasma in symptomatic knee osteoarthritis: a consensus statement from French-speaking experts. Eymard, F., Ornetti, P., Maillet, J., 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]

A 41-year-old woman developed serum sickness disease (SSD) after her third platelet rich plasma (PRP) treatment for alopecia areata, highlighting a rare but serious adverse reaction to this generally safe procedure.

The case suggests that individuals with active autoimmune diseases, like alopecia areata, may face increased risks from PRP treatments, indicating that such conditions should be considered as significant contraindications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum sickness disease in a patient with alopecia areata and Meniere' disease after PRP procedure. Owczarczyk-Saczonek, A., Wygonowska, E., Budkiewicz, M., et al.[2019]

In a study involving 10 patients with knee internal derangements, intraarticular injections of Platelet Rich Plasma (PRP) led to significant improvements in knee function and pain relief, as measured by various clinical scores at 4 and 12 weeks post-treatment.

The study demonstrated that PRP injections are a safe and effective conservative treatment option for knee injuries, with no reported adverse reactions and high patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Intraarticular Platelet Rich Plasma (PRP) Injection in Patients with Internal Knee Derangements. Razaq, S., Ejaz, A., Rao, SE., et al.[2016]

In a study of nine women with knee osteoarthritis, intra-articular injections of leukocyte-poor platelet-rich plasma (LP-PRP) led to significant improvements in functional knee scores over a three-year follow-up, particularly in gait and stair navigation.

Most patients (six out of eight) did not require additional treatment, and while some radiological progression was noted, the overall safety and feasibility of LP-PRP injections were confirmed, with no worsening of osteoarthritis in the majority of participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-Articular Leukocyte-Poor Platelet-Rich Plasma Injections for Japanese Patients With Osteoarthritis of the Knee: A Three-Year Observational Retrospective Study After Phase 1 and Phase 2a Trials. Taniguchi, Y., Yoshioka, T., Sugaya, H., et al.[2022]

Citations

1. 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 ...

2. 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.

3. 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 ...

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

Platelet-rich plasma therapy for knee osteoarthritis This retrospective observational study analyzed PRP treatment data for KOA in our hospital from January 2020 to May 2024 which was registered in the NRMD.

5. journaloei.scholasticahq.com journaloei.scholasticahq.com/article/117195-platelet-rich-plasma-injection-in-knee-osteoarthritis-results-after-four-years

Platelet rich plasma injection in knee osteoarthritis: results ... This study confirmed that a single PRP injection can provide a long-term effect in pain reduction and functional status improvement in KOA, despite the ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37441691/

Efficacy and safety of platelet-rich plasma injections for the ... PRP injection therapy can safely and effectively improve functional activity in patients with OA and produce positive analgesic effects in patients with KOA, ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39569300/

Efficacy and Safety of Platelet-Rich Plasma (PRP) Intra ... In conclusion, PRP injections appear to be a safe and effective treatment option for managing hip OA, with favorable outcomes compared to ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0974322725000171

Safety and efficacy of platelet-rich plasma injections in ... Intra-articular PRP injections in thumb CMC OA yields favorable outcomes for pain relief and hand function without major complications.

9. academic.oup.com academic.oup.com/milmed/article/189/11-12/e2347/7616422

A Comprehensive Summary of the Meta-Analyses and ... The effect of PRP injections on pain was found to be positive based on the 19 publications that reported results. While some studies observed no ...