Autologous Serum Eye Drops: Storage in freezer for up to 6 months is ok.

 2012 Nov;31(11):1313-8. doi: 10.1097/ICO.0b013e3182542085.

Stability of serum eye drops after storage of 6 months.


Department of Periodontology, University of Wuerzburg, Wuerzburg, Germany.



Serum eye drops are used for the treatment of ocular surface disease (eg, Sicca syndrome). The objective of this experimental study was to investigate whether they maintain their wound-healing potency after a prolonged storage of 6 months at -20 °C and to find a parameter that can serve as a quality and stability indicator.


After obtaining whole blood from 10 volunteers and preparing 100% (AS100), 50% (AS50), and 20% (AS20) serum eye drops, epitheliotrophic factors including EGF, fibronectin, vitamins A and E, albumin, and immunoglobulin A were quantified before and after storage for 7 days at 6 °C or 3 and 6 months at -20 °C. Human corneal epithelial (HCE) cell lines were used to investigate proliferation, migration, and overall wound healing potency of the cells in response to different serum preparations. The proliferation, migration, and wound healing of HCE cells were measured after incubation with different serum eye drop concentrations and after different storage conditions.


The concentration of epidermal growth factor, fibronectin, vitamins A and E, immunoglobulin A, and albumin showed no significant reduction over the test period. Proliferation, migration, and wound healing of HCE cells was significantly better after incubation with undiluted serum in comparison with diluted serum. No significant loss of cytokine concentration, wound healing, and proliferation effect in HCE culture of AS100, AS50, and AS20 could be detected over the 6 months of storage.


The concentration of a spectrum of cytokines involved in corneal epithelial wound healing and the epitheliothrophic effect of serumare not significantly changed after a prolonged storage of 6 months at -20 °C. Hence, it seems justifiable to provide patients with appropriate freezer capacity with a 6-month supply of autologous serum eye drops. Albumin–which is known to be relevant for ocular surface health–could serve as a cost-effective parameter for stability controls.

AUTOLOGOUS (means it comes from the patient) SERUM (the liquid or clear part of a patient’s blood that is separated from the red blood cells or cellular part) has been used for years to treat a wide variety of eye surface disorders, such as severe dry eye corneal infections and ulcers, and other ocular surface disorders, such as Sjögren’s syndrome (SS), superior limbic keratoconjunctivitis, graft-versus-host disease, Stevens-Johnson syndrome, ocular cicatricial pemphigoid, recurrent corneal erosions, neurotrophic keratopathy, Mooren’s ulcer, aniridic keratopathy, and postkeratorefractive surgery. 
I have prescribed AS for almost 18 years to help a patient’s eye heal faster from inflammation, infection, autoimmune diseases, or other disorders. 
AS has been proven to maintain the shape and function of the corneal cells much better
than pharmaceutical tear substitutes, since its biological properties are similar
to natural tears as it contains a complex composition of water, salts, proteins,
vitamins, lipids, immunoglobulines and growth factors which are similar or even better in some cases than the biological nutrients that are found in a “good” or normal tears []. Serum and tears show similar constituent concentrations, with the exception of greater amounts of vitamin A, lysozyme, transforming growth factor-β (TGF-β), and fibronectin and reduced amounts of immunoglobulin A (IgA), epithelial growth factor (EGF), and vitamin C in serum compared with tears []. 

 AS eye drops are prepared as unpreserved diluted blood solutions [].
severe dry eyes intractable to common therapy and certain corneal ulcers and
wounds. The blood serum is the fluid component of full blood which remains
after clotting. “Autologous” means that the blood to be used in the preparation
of the serum will be the the patient’s own blood. Blood serum drops have been
proven to maintain the shape and function of the corneal cells much better
than pharmaceutical tear substitutes, since its biological properties are similar
to natural tears as it contains a complex composition of water, salts, proteins,
vitamins, lipids, immunoglobulines and growth factors.
Even though many doctors and scientists worldwide have conducted studies that
show the benefits of using autologous serum drops, the US does not currently
have a Food and Drug Administration (FDA)-approved protocol or giudance for
this process.
To make your eyedrops we will need to collect some of your blood in several
tubes and it will need to be allowed to clot for one to two hours. Then it will
be placed into a machine that spins the blood at a very high speed, causing
the red cells to separate from the serum. The serum will be taken and mixed
with artificial tears or balanced saline solution at a specific concentration.
The bottles need to be kept in your freezer at home and you will
to remove one bottle at the time, leaving it to thaw in the refrigerator at all times. 
After thawing, the bottle should be kept in the refrigerator. Your eyeMD
will advise you how frequently you should use the drops, but the most common recommendation is to apply the drops four times daily. Some can feel relief with just 2x per day; some patients need to use them every hour. 
This therapy is is restricted to individual physicians for their patients only. It is not covered under medical insurances and the patients are responsible for their cost.
AS eye drops improve the quality of life of severe dry eye patients, although reports of the correlation between this improvement and clinical measurements are scarce in the literature. There is no standard dilution of serum for use in anterior segment applications as each patient may respond differently to different dilutions. We usually start at 20% dilution unless a request for a stronger % to see if this works well. The more diluted the AS, the longer it will last. Some patients need 50% dilution. Some need 100% to feel relief. Time will tell what is the most diluted % of AS the patient can use and still feel relief.

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