May 29, 2014
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Topically administered lyophilized amnion fragments a possible alternative to graft surgery

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MILAN — Freeze-dried amniotic membrane elements administered to the eye topically represent a revolutionary transplantation technique without the use of surgery, according to a presenter here.

The technique, called elemental unit transplantation, is the result of 12 years of research by Kenneth R. Kenyon, MD, and Emiliano Ghinelli, MD. Ghinelli presented the technique, which was recently approved by the Institute of Health in Italy, at the annual joint meeting of Ocular Surgery News and the Italian Society of Ophthalmology. 

Ken Kenyon

Kenneth R. Kenyon

“Using a special freeze-drying technique, we have been able to separate individual, 21 µm³ fragments of amnion, which contain all the layers and maintain all the characteristics of the original tissue,” Ghinelli said.

Dispersed in a balanced salt solution or gel vehicle, the elemental units are delivered as simple eye drops to the eye surface and penetrate the hydrophilic layer of the tear film when the patient blinks his or her eye. 

“The effect is the same of amnion patch transplantation. These particles protect the ocular surface, promote reepithelialization, inhibit fibrosis and neovascularization, and relieve from pain,” Ghinelli said.

Elemental unit transplantation can be used effectively as a treatment for ocular pathologies such as chronic corneal ulcerations, partial corneal limbus deficiency and bullous keratopathy.  Administration can be repeated until complete healing is achieved. 

A non-surgical alternative offers patients a number of advantages, including financially, according to Ghinelli.

“The costs related to the surgical procedure, but also to the procurement and cryopreservation of the amnion grafts, are avoided. Stocked at room temperature, the elemental unit preparation can be kept on the shelf for 5 years,” he said.

Disclosure: Ocular Surgery News could not confirm any relevant financial disclosures.