Mario Gimona,
Head of Manufacturing, GMP Unit,
Paracelsus Medical University Salzburg
Mario Gimona received his PhD in Genetics and Cell Biology in 1990 and spent his postdoctoral period at the Cold Spring Harbor Laboratory in New York. He has led research labs in Austria and Italy and was awarded a Marie Curie Excellent Grant by the European Union in 2004. Since 2012 he heads the GMP stem cell and EV production unit at PMU and leads a team of researchers investigating the potential of MSC-derived EVs and CDVs in regenerative medicine for application in acute spinal cord injury and for the reduction of scar formation following implant-induced injury.
First-In-Human Application of Umbilical Cord MSC-Derived EVs for the Prevention of Cochlear Implant Surgery-Related Injury
Friday, 1 November 2019 at 15:30
Add to Calendar ▼2019-11-01 15:30:002019-11-01 16:30:00Europe/LondonFirst-In-Human Application of Umbilical Cord MSC-Derived EVs for the Prevention of Cochlear Implant Surgery-Related InjuryExosomes-EV-based Therapeutics Summit in Rotterdam, The NetherlandsRotterdam, The NetherlandsSELECTBIOenquiries@selectbiosciences.com
Cochlear implantation (CI) can restore hearing perception by bypassing the auditory hair cells (HC) and directly stimulating the spiral ganglion neurons (SGN). Insertion of an electrode array into the cochlea is associated with robust early and chronic inflammatory responses that promote intra-cochlear fibrosis and loss of HC and SGN. Conservation of residual hearing and prevention of fibrous tissue deposition around the electrode are thus major challenges in CI surgery. We have manufactured GMP-compliant umbilical cord (UC)-MSC- derived extracellular vesicles (EVs) and subjected such preparations to a series of in vivo and in vitro assays. Animal studies included both systemic and local injection for the improvement of seemingly unrelated indications such as critical size bone defects, partial tendon rupture and spinal cord injury in a rat contusion-model. In all cases EV application resulted in a significant modulation of immune reaction, overall reduced inflammation and scar reduction as evidenced by a reduction in ECM deposition. In an in vitro spiral ganglion neuron protection assay UC-MSC-EVs outperformed the current best-in-class soluble neuroprotective factor, BDNF. In vivo application of EVs in mice challenged by noise trauma resulted in significant protection of hearing when compared to untreated controls. Reduction of impedance as a measure for current resistance and fibrotic tissue formation around the electrode array were observed in a model of implantation trauma in guinea pigs implanted with an electrode array. After careful consideration of the medical history of a patient requiring CI surgery an experimental healing attempt was performed and the patient received a single intra-cochlear injection of 5 x 109 EVs (total) prior to electrode insertion. The application was tolerated well, no adverse reactions were recorded and robust auditory sensation was detected 6 weeks post surgery. Based on these initial safety data on the local application of EVs in the inner ear, a phase 1/2a clinical trial is currently in preparation to further evaluate the neuroprotective, immunomodulatory and anti-fibrotic potential of UC-MSC-EVs.
Add to Calendar ▼2019-11-01 00:00:002019-11-01 00:00:00Europe/LondonExosomes-EV-based Therapeutics SummitExosomes-EV-based Therapeutics Summit in Rotterdam, The NetherlandsRotterdam, The NetherlandsSELECTBIOenquiries@selectbiosciences.com
Add to Calendar ▼2019-11-01 15:30:002019-11-01 16:30:00Europe/LondonFirst-In-Human Application of Umbilical Cord MSC-Derived EVs for the Prevention of Cochlear Implant Surgery-Related InjuryExosomes-EV-based Therapeutics Summit in Rotterdam, The NetherlandsRotterdam, The NetherlandsSELECTBIOenquiries@selectbiosciences.com
