Research is carried out in a cleanroom environment in the GMP laboratory (Photo: PMU/wildbild)

8. June 2021

How to promote better integration of cochlear implants

Tiny particles released by human stem cells are called extracellular vesicles. The world’s first administration of therapeutics based on vesicles took place in Salzburg. This allows, among other things, hearing implants to heal better. The research team led by Mario Gimona and Eva Rohde discovered that vesicles can do much more than previously thought.

Vesicles have the ability to suppress inflammatory processes and thus reduce scarring. These properties offer numerous possibilities for application in modern medicine. In the renowned journal “Journal of Extracellular Vesicles”, Salzburg researchers Mario Gimona and Eva Rohde report on their research on vesicles and their help in healing hearing implants.

Hearing implants often associated with inflammation

Hearing loss is the most common neurodegenerative disorder in humans, affecting over 450 million people worldwide. For many patients, surgical insertion of a hearing implant is required. However, side effects can occur, such as acute or chronic inflammation due to the procedure itself or as a reaction to the foreign body. These can further damage the already diseased inner ear. The destruction of additional inner ear cells can lead to the complete disappearance of the remaining hearing ability. Currently, there are no accompanying therapies for the insertion of hearing implants.

Vesicle therapy protects the ear during hearing implantation

In their preliminary work, Salzburg researchers Mario Gimona and Eva Rohde were able to show that the administration of the so-called nanovesicular therapeutic after noise damage can protect the sensory cells in the ear and reduce hearing loss. The research was carried out in cooperation with the Hannover Medical School. Therefore, the scientists suspect that vesicles from human stem cells can exert therapeutic effects in the inner ear and alleviate inflammation.

In the journal “Journal of Extracellular Vesicles,” Salzburg researchers report on the world’s first administration of the therapeutic in humans. A 24-month follow-up period is part of the study.

A patient with bilateral hearing loss received the first hearing implant in 2014. In 2018, a second identical implant was inserted, this time in combination with simultaneous administration of the nanovesicular therapeutic. During the follow-up period, there were no medical abnormalities that suggest a problematic reaction of the body to the therapeutic. On the contrary, an improvement in speech understanding was observed on the side where the therapeutic was applied. A further clinical study is currently being prepared.

Salzburg as a pioneer in vesicle research

Research in modern regenerative medicine has evolved over time from the study of precursor cells to tissue cells. This has led to the concept of using only extracellular vesicles instead of their viable parent cells. Observations of improved regeneration after strokes as well as attenuation of nerve inflammation and scar formation after spinal cord injuries have strengthened the concept of using extracellular vesicles to treat neurodegenerative diseases.

These therapies are therefore manufactured in Salzburg under the highest quality standards. The GMP laboratory of the Center for Spinal Cord and Tissue Regeneration (SCI-TReCS) at the Paracelsus Medical University Salzburg (PMU) is involved. GMP stands for Good Manufacturing Practice, which also means compliance with pharmaceutical guidelines and regulations.

Research center for therapeutic use

The goal of the Salzburg researchers is to investigate the efficacy and safety of nanovesicular therapeutics in clinical studies. For this purpose, the Transfer Center for Extracellular Vesicles Theralytic Technologies (EV-TT) was founded in 2019 by Mario Gimona and Eva Rohde (PMU) together with Nicole Meisner-Kober (PLUS). The EV-TT develops new technologies for the therapeutic use of extracellular vesicles. The focus is on supporting healing processes and drug delivery. The EV-TT is a flagship project of the Science and Innovation Strategy (WISS 2025) of the state of Salzburg and is funded by the state and the European Regional Development Fund, Investments in Growth and Employment (IWB/EFRE).

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