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 products 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 policies

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, iQOS, GLO device, Vype E-Pen, Vype e-Maxx- 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 climate controlled chamber. The exposure follows standard parameters and smoking profiles for a total of 30 minutes. After a recovery period, a battery of assays for cell viability, cytotoxicity and inflammation will be performed in the first year.

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.
These cells are exposed by an Air-Liquid Interface system housed in a climate controlled chamber. The exposure follows standard parameters and smoking profiles for a total of 30 minutes. After a recovery period, a battery of assays for cell viability, cytotoxicity and inflammation will be performed in the first year.

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, iQOS, GLO device, Vype E-Pen, Vype e-Maxx- 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 climate controlled chamber. The exposure follows standard parameters and smoking profiles for a total of 30 minutes. After a recovery period, a battery of assays for cell viability, cytotoxicity and inflammation will be performed in the first year.

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.
These cells are exposed by an Air-Liquid Interface system housed in a climate controlled chamber. The exposure follows standard parameters and smoking profiles for a total of 30 minutes. After a recovery period, a battery of assays for cell viability, cytotoxicity and inflammation will be performed in the first year.

Our Scientific Team

about us

Giovanni Li Volti

Giovanni Li Volti

Project Leader

MD, PhD and professor of Biochemistry at the School of Medicine of the University of Catania, he serves as chairman of the Department of Stress Biology, Epigenetics and Sport Medicine of the EuroMediterranean Institute of Science and Technology (IEMEST) in Palermo. His research areas of interest regard the role of oxidative stress in endothelial function, cardiovascular disease and cancer progression. Prof. Li Volti’s research team has developed extensive experience in the field of toxicology, mitochondrial function, signal transduction and cell death (apoptosis, autophagy, necrosis).

Massimo Caruso

Massimo Caruso

Co-project Leader

PhD in Respiratory Diseases, adjunct Professor of Pathology and Immunopathology and Post-doctoral Research Fellow 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

Medical doctor with PhD and residency in Immunology, he possesses a unique combination of academic knowledge in Immunology and Stem Cell Science enabling him to conduct research in immunology, drug discovery, molecular biology, bioengineering, stem cell science and translational medicine.

Ronny Lesmana

Ronny is graduated as Medical Doctor from Faculty of Medicine and Master of Health Science in 2006. He got a promotion as Assistant Professor in 2015 and to be Associate Professor in 2019. He had continue his PhD study in endocrinology and exercise in Gunma University Graduate Medical School Japan.

Kostantinos Poulas

Konstantinos Poulas studied biology at the University of Athens where he also completed his Ph.D. He has been faculty member of the Department of Pharmacy at the University of Patras. He has more than 80 publications in peer reviewed journals and he is currently participating in HORIZON2020 and national projects.

Fahad AL Zadjali

Dr. Fahad AL Zadjali has obtained PhD degree in Medical Science in 2011 from
Karolinska Institutet, Sweden. Currently Dr. Al-Zadjali is an assistant professor at
Department of Biochemistry ,College of Medicine & Health Science, at the Sultan
Qaboos University and also the deputy director of Medical Research Center at the
University.

Antonio Giordano

Antonio Giordano is an Italian-American oncologist, pathologist, genetist, researcher, professor, and writer. Dr. Giordano is the President & Founder of the Sbarro Health Research Organization (www.shro.org), Director and Professor of the Sbarro Institute for Cancer Research and Molecular Medicine and Center for Biotechnology at Temple University, College of Science & Technology in Philadelphia.

Silvia Boffo

Silvia Boffo is a Molecular Cancer Biologist originally from Venice, Italy. She received her Bachelor’s Degree and Master’s degree in Medical Biotechnologies from the University of Trieste, Italy. After her graduation, she worked as a research fellow at the National Cancer Institute in Aviano (PN), where she was involved in clinical trials aimed at personalized cancer therapies based on pharmacogenetics determinants

Sayar Abdulkhakov

Gastroenterologist and senior researcher, he is assistant Professor, Department of General Medical
Practice, Kazan State Medical
Universit.
From 2017, he works as Head of the Department of Fundamental Basis of Clinical Medicine, Institute of
Fundamental Medicine and
Biology, Kazan

Do you want more details?

Contact Us

GDPR Terms

14 + 6 =