Sjogren’s syndrome is an autoimmune disease similar to rheumatoid arthritis or lupus. Sjogren’s typically presents initially with dry eyes and dry mouth. Inflammation of the tear ducts that produce tears causes the dry condition. This disease then progresses to joint and muscle pain, fatigue and skin rashes. In severe states, the lungs, nervous system, kidneys and gastrointestinal tract can be affected. There is also an increased risk of lymphoma associated with this disease.

Women are affected 10 times more than men and the peak age of this disease is between 40 and 60.

Sjogren’s syndrome is a complex autoimmune disease. The primary manifestations include mouth and eye dryness, often accompanied or progressing to systemic complications.

Primary Sjogren’s syndrome exists where there is no underlying cause for any other rheumatic disorder. Secondary Sjogren’s syndrome coexists with a connective tissue autoimmune disease such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, dermatomyositis, or primary biliary cirrhosis.

The prevalence ranges from 0.5% to 1% of the general population.

In Sjogren’s syndrome, the immune system attacks the tear and salivary system initially. Ocular or oral dryness is present in 95-98% of SS patients and 89% have both ocular and oral symptoms. The destruction of the lacrimal gland is mediated by T lymphocytes and leads to the development of an aqueous deficient tear film over the eye. This constitutes a trigger factor for the cycle of dry eye and chronic inflammation. Then, it can attack other secretory glands in the body. The etiology is unknown but thought to be a combination of genetic, environmental and hormonal factors.

Some patients with Sjogren’s may also have one of the following symptoms:

  • Joint pain, swelling and stiffness
  • Swollen salivary glands
  • Skin rashes
  • Vaginal irritation and dryness
  • Dry persistent cough
  • Fatigue

Dry eye is the most common symptom caused by Sjogren’s syndrome. The eyes feel gritty and appear red and inflamed. Because of the chronic dryness, patients are at a high risk for eye infections and corneal damage. Common ocular symptoms include blurred vision, eye irritation, foreign body sensation and photophobia. If untreated, the chronic dryness may evolve into neurotrophic keratitis, corneal thinning and melting, ulceration and perforation. Without treatment, permanent vision threatening complications can evolve.

Treatments

Treatments for Sjogren’s are tailored to relieve the symptoms of dry eyes.

  • Artificial tears or gels. These substitutes lack ingredients found in natural tears such as proteins, lipids and growth factors.
  • Cyclosporine eye drops to increase tear production.
  • Corticosteroid drops or oral. Side effects include increasing ocular pressure as well as systemic side effects.
  • Methotrexate, Imuran, mycophenolate, rituximab, cyclophosphamide

These drugs are only used in severe cases with systemic symptoms or organ system involvement. These drugs have significant side effects.

Surgery or interventional procedures such as punctal occlusion, amniotic membrane transplantation or the implantation of a neurostimulator.

Autologous serum was first introduced in 1975 to treat ocular surface disease. In 1984, autologous serum was specifically used to treat Sjogren’s dry eyes. This was in the form of platelet poor plasma.

Platelet Rich Plasma has a huge concentration of platelets in a small volume. It has immunomodulatory and anti-inflammatory components. PRP has a significant role in regeneration, proliferation, remodeling and repair as well as the angiogenesis process.

Studies

J Clin Med 2023 May;12(9):3126 PMID 37176566

In this study comparing autologous serum versus platelet rich plasma for the treatment of dry eye caused by Sjogren’s syndrome, both were efficacious, as expected, but PRP was superior in many categories tested.

The drops were administered by one drop 5 times a day. There was no dilution of either sample, and the bottle was stored at 4 degrees C and used for one week. The remaining bottles were kept at -20 degrees until use. It was reported that blood products may be used safely when these protocols are followed. It was further noted that blood derived products such as these eye drops can be stored liquid at 4 degrees C for up to one month or frozen at -20 degrees C for up to 3-6 months but should be stored in the dark to avoid degradation of vitamin A.

PRP eye drops stored at 4 degrees C for 4 weeks had higher concentrations of growth factors than autologous serum.

It was also noted in this study that TGF-B concentration was 5 times higher in the serum and PRP than in normal tears. Therefore, some authors suggested diluting the samples to diminish the concentration since these are anti-proliferable and pro-fibrotic factors. However, the dilution process led to a decrease not only of TGF-B concentrations but also many other growth

factors with regenerative potential properties. The samples used were not diluted and safety and efficacy of undiluted PRP eye drops were demonstrated in this study.

In Ocular Surface Disease Index scores, a reduction was noted in the autologous serum group of 77.3% over baseline versus 100% in the platelet rich plasma group.

Conclusion: Dry eye is an extremely common problem. Over 300 million people worldwide suffer from some degree of dry eye. Blood derivates have a significant positive therapeutic role in the treatment of dry eye due to the huge quantity of growth factors that promote wound healing at the damaged ocular surface. The treatment with PRP, as presented, resulted in a significant improvement in the signs and symptoms of dry eye accompanying Sjogren’s syndrome.

Br J Opthalmol 2018 Jul 3:bjopthalmol 2018-312072 PMID 29970389

Background: To evaluate the effectiveness of platelet rich plasma injections in the treatment of severe dry eye

Conclusion: PRP injection is safe and effective in improving tear parameters as well as subjective parameters and was found to be superior to hyaluronic acid alone in the management of patients with severe dry eye. This represents a novel alternative treatment for severe dry eye.

Efficacy and Safety of Treatment of Hyposecretory Dry Eye with Platelet Rich Plasma

Acta Opthalmol 2019 Mar;97(2): e170-e178 PMID 30450721

Objective: To evaluate and compare the symptomatology and clinical findings in hyposecretory dry eye comparing the treatment with platelet rich plasma and artificial tears of sodium hyaluronate

Conclusion: PRP treatment in hyposecretory dry eye induces a more significant positive effect over symptomatology and different dry eye signs than sodium hyaluronate, especially in moderate and severe cases.

Autologous Serum Tears: Long term Treatment in Dry Eye Syndrome

J Fr Opthalmol 2018 Mar;41(3):246-254 PMID 29602451

Introduction: Dry Eye disease is a multifactorial pathology of the ocular surface. The high incidence of this pathology, as well as its significant impact on quality of life and vision and its financial cost, makes it a real public health problem. While the treatment of mild cases is generally simple and effective, treatment of severe forms is often disappointing. The use of autologous serum tears represents a therapeutic alternative for most of the cases. The purpose of our study is to evaluate the efficacy of long-term treatment in patients with severe dry eye disease refractory to conventional treatment of secondary to systemic diseases such as Sjogren’s Syndrome.

Conclusion: 83 eyes treated, clinical efficacy was noted in most of the patients. No infectious complications were reported, and the satisfaction rate was very high.

Juventix Regenerative Medical is an industry leader in the regenerative medical field. Our Platelet Rich Plasma Kits are FDA cleared and designed for safety, sterility and effectiveness. Our kits are scientifically manufactured to provide a platelet concentrate, devoid of red blood cells with a minimum number of leukocytes, critical to the regenerative process.

Juventix Regenerative Medical offers a patent pending LED Activator to activate the platelets and begin the regenerative process. The activation is a critical step in the release of cytokines, growth factors and bioactive proteins from the alpha granules on the platelets and is accomplished with LED light. This negates the use of chemical additives such as Calcium Chloride, Thrombin or Collagen. This activation process by LED light also provides sustained growth factor release versus older methods of activation while adhering to the minimal manipulation guideline of the FDA.

Juventix Regenerative Medical supplies a Bio-Incubator that transforms the Platelet Rich Plasma into an Injectable Platelet Rich Fibrin. The Platelet Rich Fibrin, commonly called the “second generation of platelet products” has different cytokines and growth factors than the original PRP. These different cytokines provide an anti-inflammatory environment and can be used confidently in inflammatory conditions.

Juventix Regenerative Medical has many products, services and devices for the regenerative medical professional including tissue based therapeutic products such as exosomes, offered through our collaboration with Evolutionary Biologics.

RESTORE, REVIVE, REGENERATE- JUVENTIX REGENERATIVE MEDICAL

 

Regenerative Regards,

 

Dr. Robert McGrath

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