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

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

Compensation: Varies

Number of Visits: 8

Duration: 12 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a randomized, double-blind, placebo-controlled phase 2 study with a secondary crossover phase at the end of the initial trial to ensure all subjects receive one PRP injection. The goal is to identify what proteins change in the blood following repeated intraarticular knee PRP injections in patients with knee osteoarthritis. The objective is to determine the protein changes resulting from a single autologous PRP injection (5 mL) in comparison to a normal saline control. About 60 subjects will take part in this study by two age groups at UCSF into the following arms: Arm A: PRP injection; Arm B: normal saline injection control. The study aims to demonstrate what benefits PRP has on knee osteoarthritis and methods to best achieve biologic effects. Subjects with a diagnosis of knee osteoarthritis ages 18-45 and 46-70 years old presenting to a University Based sports medicine clinic will be screened for potential eligibility. Subjects who meet all qualifying requirements will be recruited from UCSF's orthopedic and primary care clinics. Subjects will be on study for up to 26 weeks Screening: up to 14 days Treatment: injection of PRP or normal saline; subjects can cross over at week 12 to a PRP if originally in the control injection group Follow-up: 2 weeks post-baseline injection, 12 weeks postbaseline, (14 weeks if crossover patient), 26 weeks.

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.

What data supports the effectiveness of this treatment for osteoarthritis?

Research shows that platelet-rich plasma (PRP) injections can help reduce pain and improve function in people with knee osteoarthritis, although results can vary due to differences in how PRP is prepared and used. ^{1 2 3 4 5}

Is PRP injection safe for treating osteoarthritis?

Research suggests that PRP injections are generally safe for treating osteoarthritis, with studies confirming their safety and rare adverse reactions. ^{6 7 8 9 10}

How is PRP treatment different from other treatments for osteoarthritis?

PRP (platelet-rich plasma) injections are unique because they use components from your own blood to potentially improve joint function and reduce pain in osteoarthritis. Unlike other treatments, PRP is a minimally invasive injection that may have disease-modifying effects, although its exact mechanism and optimal preparation are still being studied. ^{3 4 11 12 13}

Research Team

Anthony Luke, MD, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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) Experimental Treatment 2 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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma injections in osteoarthritis of the knee: a systematic review and meta-analysis. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Role of platelet-rich plasma in early osteoarthritis of knee joint: Experience from a tertiary care center in Pakistan. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Single Injection of High Volume of Autologous Pure PRP Provides a Significant Improvement in Knee Osteoarthritis: A Prospective Routine Care Study. [2020]

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

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

6. United States 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. [2022]

7. United States 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. [2022]

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

Editorial Commentary: Platelet-Rich Plasma: Fountain of Youth, Cart Before the Horse, or Both? [2019]

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

Serum sickness disease in a patient with alopecia areata and Meniere' disease after PRP procedure. [2019]

10. Pakistan pubmed.ncbi.nlm.nih.gov

The Role of Intraarticular Platelet Rich Plasma (PRP) Injection in Patients with Internal Knee Derangements. [2016]

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

Platelet-Rich Plasma Injections for Advanced Knee Osteoarthritis: A Prospective, Randomized, Double-Blinded Clinical Trial. [2022]

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

Leukocyte-Rich versus Leukocyte-Poor Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Trial. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Intra-articular injections of platelet-rich plasma in symptomatic knee osteoarthritis: a consensus statement from French-speaking experts. [2022]