PRP Injections for Hemophilia

Overseen By Luke A Johnson, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must not be taking: Corticosteroids

Disqualifiers: Recent surgery, Joint replacement, Thrombocytopenia, BMI over 50, others

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

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

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether platelet-rich plasma (PRP) injections can safely and effectively treat joint problems in people with hemophilia, a condition where bleeding in the joints causes pain and swelling. PRP, derived from a person's own blood, might offer an affordable treatment option without requiring specialized equipment. Suitable candidates have ongoing joint issues in the ankle, knee, or elbow that haven't improved with treatments like medication or physical therapy. Participants will visit the clinic once or twice and answer questions by email, text, or phone over six months. As an unphased trial, this study provides a unique opportunity to explore innovative treatments for joint issues in hemophilia patients.

Do I have to stop taking my current medications for the trial?

The protocol does not specify if you need to stop taking your current medications. However, if you have had a corticosteroid injection or are currently taking corticosteroids, you may not be eligible to participate.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have had a corticosteroid injection or taken corticosteroids in the last six months.

What prior data suggests that this method is safe for patients with bleeding disorders?

Research has shown that platelet-rich plasma (PRP) can be a safe and effective treatment for hemophilic synovitis, a joint problem caused by hemophilia. Several studies have found that PRP injections are usually well-tolerated and cost-effective. Some research suggests that PRP injections can be administered safely without expensive equipment, potentially reducing treatment costs.

However, concerns remain. While some experts believe PRP is safe for treating joint issues in hemophilia, others recommend caution and advise waiting for more evidence of its benefits. Although PRP has been studied for safety, results are mixed. Participants should consider these findings and consult healthcare professionals when deciding about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for hemophilia, which typically involve regular infusions of clotting factor replacements, Platelet-Rich Plasma (PRP) injections offer a unique approach by utilizing components derived from the patient's own blood. PRP is rich in platelets and growth factors, which may promote healing and improve clotting without the need for external factor concentrates. This treatment could reduce dependency on frequent infusions and minimize the risk of developing inhibitors, which can complicate traditional therapy. Researchers are excited about PRP because it represents a potentially more natural and individualized treatment method that could enhance the quality of life for those living with hemophilia.

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

Research has shown that platelet-rich plasma (PRP), which participants in this trial will receive, might help treat joint problems in people with hemophilia. One study found that PRP significantly reduced bleeding episodes and pain. Another study showed that younger patients with joint disease due to hemophilia experienced noticeable improvements in their symptoms. However, some research found that PRP was not more effective than a placebo for knee problems over two years. Despite these mixed results, PRP remains an option worth considering for joint issues in bleeding disorders. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with hemophilia who suffer from hemarthropathy, a condition causing joint pain and swelling due to bleeding. Participants must be able to attend 1-2 clinic visits and complete surveys over six months.

Inclusion Criteria

I have joint pain in my ankle, knee, or elbow confirmed by X-rays in the last 2 years.

I have tried standard treatments like medication or physical therapy for over six weeks without improvement.

Exclusion Criteria

I had surgery on the joint in question within the last two years or have had it replaced.

Body mass index (BMI) over 50

I have had an orthobiologic injection in my affected joint.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive two ultrasound-guided intra-articular joint injections of low-cost platelet-rich plasma (LC-PRP) at day 0 and 3 weeks

3 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collection at 0, 1, 3, and 6 months after the second injection

6 months

Electronic follow-up via email, text message, in person, and/or by telephone

What Are the Treatments Tested in This Trial?

Interventions

• Platelet-Rich Plasma

Trial Overview

The study tests low-cost platelet-rich plasma (PRP) injections as a treatment for joint issues in hemophilia patients. It aims to prove that PRP can be administered safely without expensive equipment while monitoring outcomes.

How Is the Trial Designed?

Group I: PRP Injection Experimental Treatment 1 Intervention

45mL of blood is drawn from the subject in a standard-of-care manner into 3 x 20mL syringes, each containing 2mL of sodium citrate (anticoagulant). Each syringe is prepared and capped, then placed into a centrifuge. The resulting separated blood is then drawn off into a single new sterile syringe, which can be used for the injection. Blood and PRP analysis: We will perform a full analysis (a complete blood count \[CBC\] with differential) on subjects' whole blood and their prepared LC-PRP. Importantly, we will include all data required in the PRP minimum reporting standards, including "platelet, differential leukocyte, and red cell analysis of all samples."

Platelet-Rich Plasma is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Platelet-Rich Plasma for:

• Hip labral tears
• Osteoarthritis
• Musculoskeletal injuries

Approved in European Union as Platelet-Rich Plasma for:

• Orthopedic conditions
• Sports injuries
• Degenerative joint diseases

Approved in Canada as Platelet-Rich Plasma for:

• Musculoskeletal disorders
• Joint pain
• Soft tissue injuries

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

Autologous plasma rich in platelets (PRP) has shown to improve gingival recession in chronic periodontitis, with a significant effect size (SMD of 0.54) based on data from four randomized controlled trials.

The efficacy of PRP in promoting complete healing of chronic skin ulcers remains inconclusive, and while adverse effects were reported, there were no significant differences between treatment groups, indicating a need for further research on its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. Martínez-Zapata, MJ., Martí-Carvajal, A., Solà, I., et al.[2018]

In a study involving six patients with hemophilia, autologous platelet-rich plasma (PRP) injections into the ankle joints led to significant pain relief, as measured by the Hemophilia Joint Health Score and Visual Analog Scale, two months post-treatment.

MRI results showed a decrease in the volume of free synovial fluid, indicating a reduction in synovitis, which suggests that PRP therapy may effectively improve joint health in patients with chronic hemophiliac synovitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of platelet-rich plasma on chronic synovitis in hemophilia. Teyssler, P., Kolostova, K., Bobek, V.[2014]

In a study of 140 high-risk women undergoing cesarean sections, the use of autologous platelet-rich plasma (PRP) significantly improved wound healing compared to standard care, with an 85.5% reduction in the REEDA score for the PRP group versus 72% for the control group.

Patients receiving PRP also reported greater pain relief, with a 93% reduction in the visual analog scale (VAS) score compared to 79% in the control group, indicating that PRP not only enhances healing but also improves patient comfort post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Autologous Platelet-Rich Plasma (PRP) on Wound Healing After Caesarean Section in High-Risk Patients. Tehranian, A., Esfehani-Mehr, B., Pirjani, R., et al.[2022]

In a study involving 22 patients with haemophilic arthropathy, a single intra-articular injection of platelet-rich plasma (PRP) provided better pain relief and improved knee joint function compared to five weekly injections of hyaluronic acid (HA) over a 6-month period.

The PRP group showed a sustained beneficial effect, with significant reductions in pain and synovial hyperaemia, suggesting that PRP could be an effective treatment option for patients with haemophilic knee arthropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory comparison of single intra-articular injection of platelet-rich plasma vs hyaluronic acid in treatment of haemophilic arthropathy of the knee. Li, TY., Wu, YT., Chen, LC., 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]

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]

A systematic review of nine randomized controlled trials involving 325 participants found no significant difference in the healing of chronic wounds when comparing autologous platelet-rich plasma (PRP) to standard treatments or placebo.

While some results showed a higher percentage of wound area healed with PRP in mixed chronic wounds, overall evidence does not support the efficacy of PRP for chronic wound treatment, highlighting the need for more robust clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. Martinez-Zapata, MJ., Martí-Carvajal, AJ., Solà, I., 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]

Allogeneic platelet-rich plasma (PRP) is a promising alternative for wound treatment when autologous PRP is not available, showing no major side effects and generally leading to faster healing or reduced wound size in most studies reviewed.

Despite the positive outcomes, the efficacy of allogeneic PRP needs to be confirmed through larger studies with standardized preparation methods and control groups, as the current literature shows inconsistencies in treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allogeneic Platelet-Rich Plasma: Is It Safe and Effective for Wound Repair? Akbarzadeh, S., McKenzie, MB., Rahman, MM., et al.[2021]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35638918/

No Benefit to Platelet-rich Plasma Over Placebo Injections ...

Three intraarticular PRP injections, compared with placebo injections, did not improve hemophilic knee symptoms, function, and quality of life over 24 months.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06543368

Low-Cost Platelet-Rich Plasma for Hemarthropathy

This study intends to show that low-cost PRP can be done safely in patients with bleeding disorders, without the need for expensive equipment.

3.

tandfonline.com

tandfonline.com/doi/abs/10.1080/17474086.2023.2166922

Intra-articular injection of platelet-rich plasma in patients ...

After a 24-month follow-up, the PRP injections did not reduce pain or increase function or quality of life with respect to placebo. This level 1 evidence study ...

4.

mdpi.com

mdpi.com/1422-0067/25/17/9140

Treatment of Chronic Haemophilic Synovitis with PRP

Clinically, it is demonstrated that PRP is effective in reducing bleeding episodes (p < 0.001) and pain (p < 0.0001) and improving the ...

5.

researchgate.net

researchgate.net/publication/348552464_The_Efficacy_of_Platelet-Rich_Plasma_in_the_Treatment_of_Hemophilic_Arthropathy

The Efficacy of Platelet-Rich Plasma in the Treatment ...

The mean age of the participants was 14.7 years (range, 9-19 years). In all patients, statistically significant improvements were noted on all ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11395128/

Treatment of Chronic Haemophilic Synovitis with PRP

We conclude that PRP can be considered an effective, safe, and easy treatment for hemophilic synovitis.

7.

rarediseaseadvisor.com

rarediseaseadvisor.com/news/prp-injections-hemophilia-joint-disease/

Intra-articular PRP Injections Not Appropriate in Hemophilia

Intra-articular platelet-rich plasma (PRP) injections should not be used in patients with hemophilia until there is further evidence of its benefits.

8.

withpower.com

withpower.com/trial/phase-hemophilia-a-6-2024-3ec6c

PRP Injections for Hemophilia · Info for Participants

A systematic review of nine randomized controlled trials involving 325 participants found no significant difference in the healing of chronic wounds when ...