Replication Study

A neglected tool that will ensure validity of published data.

Replica is a CoEHAR‘s Project

What is

Replica

The “In vitro Replication study” project coordinates the Leading Center at CoEHAR with five academic laboratories in Indonesia, Oman, Russia, Serbia and USA and one academic affiliated laboratory in Greece. This team will conduct an Inter-laboratory study for a duration of 4 years. During the life span of the project they will test the latest generation of alternative products to conventional cigarettes, to assess cell and tissue cytotoxicity, oxidation, mutagenicity and genotoxicity.

What are

Replica’s GOALS

Replication

Replicate high-profile in vitro studies testing next generation products (NGPs)

R

Validation

Assess validity of the original work put under scrutiny

Information

To inform the scientific academia and the public of the progress

Contribution

Contribute to the amelioration of local and international THR policies

In recent years, there has been an advancement in technologies capable to simulate human smoking and to recreate closer physiological conditions for in vitro studies of smoke and aerosol cell exposure.

Based on these advancements our team of scientists have decided to replicate, for the first year of the study, three published works from the Tobacco Industry focusing on toxicological assessment and inflammation.

They will use state-of-the-art equipment capable to simulate smoking and vaping conditions. Briefly, standardized smoking and vaping machines will be used to test next generation products, electronic cigarettes and tobacco heating products, and compare to a 1R6F, the reference tobacco cigarette from the University of Kentucky. The smoke or aerosol generated is canalized and delivered to Human bronchial epithelial cells.

These cells are exposed by an Air-Liquid Interface system housed in a temperature controlled chamber. The exposure follows standard parameters and smoking profiles.

After a recovery period, a battery of assays for cell viability, cytotoxicity and inflammation will be performed.

2D and 3D cell cultures will be used in the following years for genotoxicity and mutagenesis studies. Support tests of great scientific profile will be conducted to increase robustness of the data.

Also, chemical analysis will be performed on conditioned filters (Cambridge Filter Pads) and in culture media for Nicotine dosimetry for system characterization and to compare magnitude of exposure of cells to the different products and for nicotine normalization of the test products.

In recent years, there has been an advancement in technologies capable to simulate human smoking and to recreate closer physiological conditions for in vitro studies of smoke and aerosol cell exposure.

Based on these advancements our team of scientists have decided to replicate, for the first year of the study, three published works from the Tobacco Industry focusing on toxicological assessment and inflammation.

They will use state-of-the-art equipment capable to simulate smoking and vaping conditions. Briefly, standardized smoking and vaping machines will be used to test next generation products, electronic cigarettes and tobacco heating products, and compare to a 1R6F, the reference tobacco cigarette from the University of Kentucky. The smoke or aerosol generated is canalized and delivered to Human bronchial epithelial cells.

These cells are exposed by an Air-Liquid Interface system housed in a temperature controlled chamber. The exposure follows standard parameters and smoking profiles.

After a recovery period, a battery of assays for cell viability, cytotoxicity and inflammation will be performed.

2D and 3D cell cultures will be used in the following years for genotoxicity and mutagenesis studies. Support tests of great scientific profile will be conducted to increase robustness of the data.

Also, chemical analysis will be performed on conditioned filters (Cambridge Filter Pads) and in culture media for Nicotine dosimetry for system characterization and to compare magnitude of exposure of cells to the different products and for nicotine normalization of the test products.

Our Scientific Team

about us

Giovanni Li Volti

Project Leader

Detailed Bio

Giovanni Li Volti graduated from the School of Medicine of the University of Catania (Italy) in 2000 and obtained a PhD in Pediatric Sciences in 2005 in the same school.

He worked as research associate from 2000 to 2002 at the Department of Pharmacology of the New York Medical College (USA). From 2005 to2006 he was post-doc at the Department of Anatomy of the University of Brescia (Italy).

During these years he worked extensively on oxidative stress and natural antioxidants under various experimental conditions both in vitro and in vivo. From 2006 he is associate professor of Biochemistry at the School of Pharmacy of the University of Catania where he continued his work on natural extracts and oxidative stress with particular regard to metabolic syndrome and neurodegenerative diseases.

From 2019 he if full professor of Biochemistry at the School of Medicine of the University of Catania where he serves as a deputy rector for biomedical research. Prof. Li Volti received several awards for his research including Aventis Pharma New Investigator Award for U.S. Fellow and Young Scientist Award FEBS meeting. He is also recipient of various funded scientific grants related to oxidative stress and antioxidants.

He is author of more than 230 peer reviewed articles and he is currently serving as a member and associate editor in various high ranked scientific journals (i.e. Journal of Clinical Medicine, Molecules, Frontiers in Pharmacology, Frontiers in Physiology, and many others).

He is currently ranked among the top Italian scientist in the world and his articles have been cited more than 5000 times (data from Scopus).

Massimo Caruso

Co-Project Leader

Detailed Bio

PhD in Respiratory Diseases, Assistant Professor of Biochemistry at the Department of Biomedical and Biotechnological Sciences, working in different projects at the Center of Excellence for the Acceleration of HArm Reduction (CoEHAR) at the University of Catania.

He is part of the team that has developed the first studies to evaluate the effectiveness of electronic cigarettes in the smoking cessation and damage assessment on asthmatic smokers and with COPD.

He is currently working on studies on the biological impact of electronic nicotine delivery systems (ENDS) for the reduction of tobacco damage in simple and complex cellular models.

Its objectives are to contribute to the determination of the critical parameters to be considered for the correct determination of damage in preclinical studies and the evaluation of possible improvements to be made to these tools to further reduce the impact on health.

International Partners

Vladislav Volarevic

Faculty of Medical Sciences, University of Kragujevac
Serbia

Ronny Lesmana

Universitas Padjadjaran
Indonesia

Kostantinos Poulas

Institute of Research and Development NOSMOKE.TEAM
Greece

Fahad AL Zadjali

Sultan Qaboos University
Oman

Antonio Giordano

Temple University-SHRO
USA

Silvia Boffo

Temple University-SHRO
USA

Sayar Abdulkhakov

Kazan Federal University
Russia

Ecig – what is different?

Exposure of cells to smoke

Ecig – what is Replica?

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