Nicola Leone

Dr. Nicola Leone

orcid

Research Focus & Metrics

Academic Career Length

28Years (1999-Present)

(Calculated once Scilit publication data is synced: current year − year of first publication + 1)

Representative Publications

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29 July 2019 in Stem Cell Research & Therapy
Verified
Journal Article
Open access
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RLRoberto Lonardi
Roberto Lonardi
NLNicola Leone
Nicola Leone
SGStefano Gennai
Stefano Gennai
GBGiulia Trevisi Borsari
Giulia Trevisi Borsari
TCTea Covic
Tea Covic
RSRoberto Silingardi
Roberto Silingardi
The diabetic foot ulcer (DFU) is one of the most prevalent complications of diabetes mellitus and often develops severe effects that can lead to amputation. A non-healing “minor” amputation often precedes a major amputation resulting in a negative impact on the function and quality of life of the patients. Stem cell-based therapies have emerged as a promising option to improve healing, and the adipose tissue is an abundant and easy to access source. The injection of autologous micro-fragmented adipose tissue at the amputation stump of a diabetic population undergoing a lower limb minor amputation was evaluated and compared with the standard care. In this randomized controlled trial with two arms (parallel assignment) and no masking, 114 patients undergoing a lower limb minor amputation were randomized to standard of care or to micro-fragmented adipose tissue injection prepared using a minimal manipulation technique (Lipogems®) in a closed system. Clinical outcomes were determined monthly up to 6 months. Primary endpoint of the study was the evaluation of the healing rate and time after the minor amputation. Secondary endpoints included the assessment of safety, feasibility, technical success, relapse rate, skin tropism, and intensity of pain. At 6 months, 80% of the micro-fragmented adipose tissue-treated feet healed and 20% failed as compared with the control group where 46% healed and 54% failed (p = 0.0064). No treatment-related adverse events nor relapses were documented, and technical success was achieved in all cases. The skin tropism was improved in the treatment group, and the pain scale did not differ between the two groups. The results of this randomized controlled trial suggest that the local injection of autologous micro-fragmented adipose tissue is a safe and valid therapeutic option able to improve healing rate following minor amputations of irreversible DFU. The technique overcomes several stem cell therapy-related criticisms and its potential in wound care should be better evaluated and the therapeutic indications could be expanded. ClinicalTrials.gov number: NCT03276312. Date of registration: September 8, 2017 (retrospectively registered).

1 April 2018 in Journal of Vascular Surgery
Verified
Journal Article
Closed access
RSRoberto Silingardi
Roberto Silingardi
SGStefano Gennai
Stefano Gennai
NLNicola Leone
Nicola Leone
MGMauro Gargiulo
Mauro Gargiulo
GFGianluca Faggioli
Gianluca Faggioli
RCRaffaele Cuomo
Raffaele Cuomo

1 August 2004 in European Journal of Gastroenterology & Hepatology
Verified
Journal Article
Closed access
NLNicola Leone
Nicola Leone
PPPaolo De Paolis
Paolo De Paolis
MCMonica Carrera
Monica Carrera
PCPatrizia Carucci
Patrizia Carucci
AMAlessandro Musso
Alessandro Musso
MRMario Rizzetto
Mario Rizzetto
Hepatocellular carcinoma (HCC) may arise in ectopic livers, which are autonomous islands of normal liver parenchyma located in the abdomen or thorax. The majority of HCCs in ectopic livers are reported in oriental patients. We describe here three new cases of HCC in Caucasian patients. The clinical presentation varied from dull epigastric pain in one patient, to abrupt onset with signs and symptoms of acute abdomen caused by intra-abdominal bleeding in another patient, to an unexplained progressive increase of alpha-fetoprotein serum levels in a third patient. None had risk factors for HCC or liver disease. One of the patients developed HCC at age 34 years; she is the youngest patient ever described to develop HCC in ectopic liver. Our data further strengthen the hypothesis that ectopic livers are particularly predisposed to developing HCC. The patients were followed up for 4 years after surgery: two remain free of disease, suggesting that the unique localisation and growth pattern may render these tumours particularly susceptible to curative resection.

29 October 2023 in Journal of Clinical Medicine
Verified
Journal Article
Open access
PDF file
NLNicola Leone
Nicola Leone
MBMagdalena Anna Broda
Magdalena Anna Broda
JEJonas Eiberg
Jonas Eiberg
TRTimothy A Resch
Timothy A Resch
Background: The ultimate goal of treating patients with abdominal aortic aneurysms (AAAs) is to repair them when the risk of rupture exceeds the risk of repair. Small AAAs demonstrate a low rupture risk, and recently, large AAAs just above the threshold (5.5–6.0 cm) seem to be at low risk of rupture as well. The present review aims to investigate the outcomes of AAAs under surveillance through a comprehensive systematic review and meta-analysis. Methods: PubMed, Embase, and the Cochrane Central Register were searched (22 March 2022; PROSPERO; #CRD42022316094). The Cochrane and PRISMA statements were respected. Blinded systematic screening of the literature, data extraction, and quality assessment were performed by two authors. Conflicts were resolved by a third author. The meta-analysis of prevalence provided estimated proportions, 95% confidence intervals, and measures of heterogeneity (I2). Based on I2, the heterogeneity might be negligible (0–40%), moderate (30–60%), substantial (50–90%), and considerable (75–100%). The primary outcome was the incidence of AAA rupture. Secondary outcomes included the rate of small AAAs reaching the threshold for repair, aortic-related mortality, and all-cause mortality. Results: Fourteen publications (25,040 patients) were included in the analysis. The outcome rates of the small AAA group (55 mm) were 25.7% (95% CI 18.0–34.3; I2 = 72.0%) of rupture, 22.1% (95% CI 16.5–28.3; I2 = 25.0%) of aortic-related mortality, and 61.8% (95% CI 47.0–75.6; I2 = 89.1%) of all-cause mortality. The sensitivity analysis demonstrated a higher rupture rate in studies including 72 years, >17% of female patients, and >44% of current smokers. Conclusion: The rarity of rupture and aortic-related mortality in small AAAs supports the current conservative management of small AAAs. Surveillance seems indicated, as one-fifth reached the threshold for repair. Large aneurysms had a high incidence of rupture and aortic-related mortality. However, these data seem biased by the sparse and heterogeneous literature overrepresented by patients unfit for surgery. Specific rupture risk stratified by age, gender, and fit-for-surgery patients with large AAAs needs to be further investigated.

7 February 2023 in Journal of Vascular Surgery
Verified
Journal Article
Closed access
SGStefano Gennai
Stefano Gennai
NLNicola Leone
Nicola Leone
LMLuca Mezzetto
Luca Mezzetto
GVGian Franco Veraldi
Gian Franco Veraldi
DSDaniele Santi
Daniele Santi
RSRoberto Silingardi
Roberto Silingardi

1 October 2005 in Digestive Diseases and Sciences
Verified
Journal Article
Closed access
PDF file
NLNicola Leone
Nicola Leone
SSSilvia Saettone
Silvia Saettone
PPPaolo De Paolis
Paolo De Paolis
PCPatrizia Carucci
Patrizia Carucci
FBFranco Brunello
Franco Brunello
MRMario Rizzetto
Mario Rizzetto