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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Orthopedic complications can be injuries or diseases that affect the bones, muscles, and joints. Hemarthropathy is due to bleeding disorders, most commonly hemophilia, and can result in severe issues related to chronic amounts of blood in the body's joints. This causes swelling, pain, and loss of joint function. A serious barrier to treating many patients with bleeding disorders creates higher health risks and costs. Platelet-rich plasma (PRP) injection is a method that can reduce the cost of care while still offering a similar standard of care for patients. This study intends to show that low-cost PRP can be done safely in patients with bleeding disorders, without the need for expensive equipment, while monitoring patient treatment results. Study participants will receive injections for joint conditions. Being in the study requires attending 1 to 2 in-person visits at the study clinic. Participants will also complete surveys using email, text messages, in person, and/or on the phone. Participation lasts about 6 months.

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 data supports the idea that PRP Injections for Hemophilia is an effective treatment?

The available research shows that PRP injections can be effective for people with hemophilia who have joint issues. In a study with six patients, all reported less pain after receiving PRP injections. The study also found a decrease in joint swelling, as seen in MRI scans. This suggests that PRP can help reduce pain and improve joint health in hemophilia patients. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment PRP injections for hemophilia?

Research shows that PRP injections can reduce pain and improve joint health in people with hemophilia, as seen in a study where patients reported less pain and showed decreased joint fluid after treatment. PRP is also known to help with healing in other conditions, like chronic wounds, due to its high concentration of growth factors. ^{1 2 3 4 5}

What safety data exists for PRP injections?

The safety of PRP injections has been evaluated in various studies. A systematic review on autologous plasma rich in platelets indicates its growing application in clinical practice, suggesting a focus on both efficacy and safety. PRP is considered one of the safest aesthetic procedures, with adverse reactions being extremely rare. A study on intraarticular PRP injections for knee issues reported significant improvement in patients with no major adverse events, indicating it is a safe and effective treatment. ^{3 4 6 7 8}

Is PRP injection generally safe for humans?

PRP injections are generally considered safe, with adverse reactions being extremely rare. Studies have shown that PRP is safe for various conditions, including wound healing and knee issues. ^{3 4 6 7 8}

Is the treatment Platelet-Rich Plasma (PRP) promising for hemophilia?

Yes, PRP is promising for hemophilia. It has shown potential in reducing pain and improving joint health in patients with hemophilia, as well as aiding in tissue regeneration and wound healing. ^{1 2 3 4 9}

How is PRP treatment different from other treatments for hemophilia?

PRP (platelet-rich plasma) treatment is unique because it uses a patient's own blood components, specifically platelets, which are rich in growth factors that can help repair tissues and reduce inflammation. Unlike traditional treatments for hemophilia that focus on replacing missing clotting factors, PRP aims to improve joint health and reduce pain by directly influencing the joint environment. ^{1 2 3 4 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. Belgium pubmed.ncbi.nlm.nih.gov

The impact of platelet-rich plasma on chronic synovitis in hemophilia. [2014]

2. England 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. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma for treating chronic wounds. [2022]

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

Efficacy and safety of the use of autologous plasma rich in platelets for tissue regeneration: a systematic review. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Allogeneic Platelet-Rich Plasma: Is It Safe and Effective for Wound Repair? [2021]

6. Estonia pubmed.ncbi.nlm.nih.gov

Application of Autologous Platelet-Rich Plasma (PRP) on Wound Healing After Caesarean Section in High-Risk Patients. [2022]

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

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

8. Pakistan pubmed.ncbi.nlm.nih.gov

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

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

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