Clinical Research

Competences are provided by a multidisciplinary and highly interactive team made up of Professors and Researchers from different Departments of the University, with proven experience in both clinical and translational research in the cardiovascular, oncology and regenerative medicine. The staff of the Clinical Research Service also has consolidated experience in the study of the efficacy and safety of drugs, active compound and molecules of neo-synthesis on microorganisms (bacteria and fungi) with relevance for humans. The preclinical experimental activity is focused on the use of cell biology (cultures in 2D (monolayer) and 3D (spheroids and organoids) and molecular biology: PCR, Real-Time PCR, Digital Droplet PCR.

• Description
• Activities

• The Clinical Research Service offers a wide range of services related to the management of randomized and / or observational studies in the biomedical field together with biomarker analysis in biological samples from subjects involved in clinical study for correlation analysis with the clinical parameters in order to evaluate the response to a treatment or understand the molecular mechanisms underlying the studied pathologies. The Clinical Research service also conducts:

  • Preclinical experimental studies aimed at testing or validating the biological or pharmacological efficacy (drug-delivery) of innovative biomaterials that can be used in clinical practice for tissue regeneration and / or the therapy of muscular and skeletal degenerative diseases
  • In vitro analysis of the effects of drugs, active compounds and neo-synthesis molecules on: bacterial and fungal cultures, biofilms and risk pathogens 3
  • In vitro analysis of the bio-adhesiveness of drugs, active ingredients and neo-synthesis molecules on cultures of gastric mucosa, vaginal mucosa or respiratory epithelium
  • In vitro analysis of the antiviral activity of compounds, drugs, neo-synthesis molecules
  • In vitro analysis of phage susceptibility on bacteria (environmental and clinical isolates)
  • Analysis of the bacterial resistome by microarray and quantitative real-time PCR
  • Preclinical experimental studies aimed at validating the biological activity of polymers and bio-inks to be used in the field of translational medicine with 3D printers.

• Thanks to the skills and technologies described above, the Clinical Research Service is able to offer the following services:

  • Market analysis
  • Feasibility studies for clinical trials
  • Development, review, finalization of documents for clinical trials (from preclinical to phase IV)
  • Regulatory activities in clinical trials
  • Training activities for staff involved in clinical trials (both by the promoter and by the participating centers)
  • Management of clinical trials at participating centers
  • Monitoring of clinical trials
  • Project management
  • Collection, evaluation and statistical analysis of data
  • Development and management of reports for the promoter / referent of the trial
  • Organization of courses and seminars for the dissemination of fundamental notions related to the conduction of clinical studies
  • Use of cellular models for the study of endothelial dysfunction and inflammatory response
  • Use of in vitro cell models to test the biological and therapeutic efficacy of innovative biomaterials
  • Use of patient-derived cells and innovative biomaterials for the preparation of personalized regenerative medicine protocols.
  • In vitro analysis of the effects of drugs, active compounds and neo-synthesis molecules on: bacterial and fungal cultures, biofilms and risk pathogens 3.
  • In vitro analysis of the bio-adhesiveness of drugs, active ingredients and neo-synthesis molecules on cultures of gastric mucosa, vaginal mucosa or respiratory epithelium
  • Access to the BSL3 laboratory of the University of Ferrara, with the possibility of carrying out analyzes and experiments on risk 3 pathogens. SARS-CoV-2 testing is currently active.
  

  Infarcted rat heart

  

  Heart with myocardial infarction

• Computers and epidemiological / statistical software. Programs for the management of core labs in the electro, echo and coronary artery fields.

• Droplet digital PCR.

Address

Clinical Research
Laboratorio per le Tecnologie delle Terapie Avanzate (LTTA)
"CUBO" Chemical Biomedical Pole Area - third floor
Via Fossato di Mortara 70 - 44121 Ferrara
+39 0532 242077

Technical Director

Prof. Gianluca Campo
cmpglc@unife.it
+39 0532 236450

Contact Person

Prof. Paola Rizzo
rzzpla@unife.it
+39 0532 242077

Staff

Prof. Fernanda Martini
Prof. Barbara Zavan
Prof. Elisabetta Caselli
Prof. Roberta Rizzo
Dott. Luisa Marracino

Arcangeletti MC, D’Accolti M, Maccari C, Soffritti I, De Conto F, Chezzi C, Calderaro A, Ferri C, Caselli E, (2020). Impact of human cytomegalovirus and human herpesvirus 6 infection on the expression of factors associated with cell fibrosis and apoptosis: clues for implication in systemic sclerosis development. International Journal of Molecular Sciences 21(17):6397. PubMed

Bortolotti D, Gentili V, Rizzo S, Rotola A, Rizzo R, (2020) SARS-CoV-2 Spike 1 Protein Controls Natural Killer Cell Activation via the HLA-E/NKG2A Pathway. Cells 26;9(9):E1975. PubMed

Caselli E, Fabbri C, D’Accolti M, Soffritti I, Bassi C, Mazzacane S, Franchi M, (2020). Defining the oral microbiome by Whole-Genome Sequencing and resistome analysis: the complexity of the healthy picture. BMC Microbiology 20:120. PubMed

Gardin C, Ferroni L, Latremouille C, Chachques JC, Mitrečić D, Zavan B, (2020). Recent Applications of Three Dimensional Printing in Cardiovascular Medicine. Cells 9(3):742. PubMed

Bortolotti D, Gentili V, Caselli E, Sicolo M, Soffritti I, D'Accolti M, Barao I, Rotola A, Di Luca D, Rizzo R, (2020) DNA Sensors' Signaling in NK Cells During HHV-6A, HHV-6B and HHV-7 Infection. Front Microbiol 11:226. PubMed

Mazzoni E, D'Agostino A, Iaquinta M R, Bononi I, Trevisiol L, Rotondo J C, Patergnani S, Giorgi C, Gunson M J, Arnett G W, Nocini P F, Tognon M, Martini F., (2019) Hydroxylapatite‐collagen hybrid scaffold induces human adipose‐derived mesenchymal stem cells to osteogenic differentiation in vitro and bone regrowth in patients. Stem Cells Transl Med 9(3): 377–388. PubMed

Iaquinta M R, Mazzoni E, Bononi I, Rotondo J C, Mazziotta C, Montesi M, Sprio S, Tampieri A, Tognon M, Martini F, (2019) Adult Stem Cells for Bone Regeneration and Repair. Front Cell Dev Biol 7:268. PubMed

Cimaglia P, Vieceli Dalla Sega F, Vitali F, Lodolini V, Bernucci D, Passarini G, Fortini F, Marracino L, Aquila G, Rizzo P, Ferrari R, Campo G, (2019) Effectiveness of a Novel Nutraceutical Compound Containing Red Yeast Rice, Polymethoxyflavones and Antioxidants in the Modulation of Cholesterol Levels in Subjects With Hypercholesterolemia and Low-Moderate Cardiovascular Risk: The NIRVANA Study. Front Physiol 10: 217. PubMed

Campo G, Vieceli Dalla Sega F, Pavasini R, Aquila G, Gallo F, Fortini F, Tonet E, Cimaglia P, Del Franco A, Pestelli G, Pecoraro A, Contoli M, Balla C, Biscaglia S, Rizzo P, Ferrari R, (2017) Biological effects of ticagrelor over clopidogrel in patients with stable coronary artery disease and chronic obstructive pulmonary disease. Thromb Haemost. 117(6): 1208-1216. PubMed

Brunello G, Sivolella S, Meneghello R, Ferroni L, Gardin C, Piattelli A, Zavan B, Bressan E, (2016). Powder-based 3D printing for bone tissue engineering. Biotechnol Adv. 34(5):740-753. PubMed

The Clinical Research Service has a rich network of collaborations in Italy and abroad. In particular, the Service is a constant and continuous collaborator of different Italian (Brescia, Udine, Verona, Salerno, Turin) and foreign Universities (Lousiana State University, Loyola University of Chicago and Harvard Medical School), public research Institutes, such as CNR of Faenza, Rizzoli IRCCS orthopedic institutes of Bologna, private health structures such as Maria Cecilia Hospital, GVM Care & Research, and companies operating in the ceramics field (Finceramica di Faenza), nutraceuticals (Incos, Castello d'Argile, Bologna), raw materials (HelixPharma srl), medical devices (FB Vision) and genomics (Genomix4life Srl). Among the collaborations abroad, the Clinical Research Service collaborates with the Almazov Cardiology Center in St. Petersburg, the Proteomics Center of the University of Utrecht, The Netherlands.

Some services/products offered can take advantage of collaboration/integration with other services of the LTTA Laboratory.
*Electronic microscopy

Each service includes the description of the procedure and the supply of images for the purpose of any scientific publications.
Prices are to be understood without VAT and subject to update according to the tariffs of consumer products required for the service (each 12 months).