Mont-Saint-Éloi, France
Mont-Saint-Éloi, France

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Lacour J.-P.,University Hospital of Nice | Ulrich C.,Charité - Medical University of Berlin | Gilaberte Y.,Hospital San Jorge | Von Felbert V.,RWTH Aachen | And 16 more authors.
Journal of the European Academy of Dermatology and Venereology | Year: 2015

Background Unmet needs exist in actinic keratosis (AK) treatment. Daylight photodynamic therapy (DL-PDT) has shown good efficacy and safety results compared to conventional PDT (c-PDT) in a recent Phase III multi-centre randomised controlled trial in Australia among 100 subjects with AKs. Objectives Demonstrate non-inferior efficacy and superior safety of DL-PDT compared to c-PDT in treating multiple mild and/or moderate facial/scalp AKs. Methods Phase III, 12 week, multi-centre, randomised, investigator-blinded, controlled, intra-individual study conducted at different latitudes in Europe. AKs of adult subjects were treated once with methyl aminolevulinate (MAL) DL-PDT on one side of the face and MAL c-PDT contralaterally. Endpoints for DL-PDT concerned efficacy (non-inferiority regarding complete lesion response at week 12) and safety (superiority regarding subject's assessment of pain after treatment, on an 11-point numeric rating scale). Safety evaluation also included incidence of adverse events. Subject satisfaction was described using a questionnaire at baseline and last visit. Results At week 12, the total lesion complete response rate with DL-PDT was similar (non-inferior) to c-PDT (70% vs. 74%, respectively; 95% CI [-9.5; 2.4] in PP analysis, confirmed in ITT analysis). In addition, efficacy of DL-PDT was demonstrated regardless of weather conditions (sunny or cloudy). DL-PDT was nearly painless compared to c-PDT (0.7 vs. 4.4, respectively; P < 0.001), better tolerated and resulted in higher subject satisfaction. Conclusion DL-PDT in comparison with c-PDT was as effective, better tolerated and nearly painless with high patient satisfaction, and may be considered a treatment of choice to meet needs of patients with mild or moderate facial/scalp AKs. © 2015 European Academy of Dermatology and Venereology.


Akil A.,French Institute of Health and Medical Research | Akil A.,University Paris - Sud | Akil A.,Institute Pasteur du Maroc | Akil A.,Mohammed V University | And 30 more authors.
Nature Communications | Year: 2016

The accumulation of lipid droplets (LD) is frequently observed in hepatitis C virus (HCV) infection and represents an important risk factor for the development of liver steatosis and cirrhosis. The mechanisms of LD biogenesis and growth remain open questions. Here, transcriptome analysis reveals a significant upregulation of septin 9 in HCV-induced cirrhosis compared with the normal liver. HCV infection increases septin 9 expression and induces its assembly into filaments. Septin 9 regulates LD growth and perinuclear accumulation in a manner dependent on dynamic microtubules. The effects of septin 9 on LDs are also dependent on binding to PtdIns5P, which, in turn, controls the formation of septin 9 filaments and its interaction with microtubules. This previously undescribed cooperation between PtdIns5P and septin 9 regulates oleate-induced accumulation of LDs. Overall, our data offer a novel route for LD growth through the involvement of a septin 9/PtdIns5P signalling pathway.


Boccara O.,Hospital Ambroise Pare | Girard C.,Hospital Saint Eloi | Mortier L.,Lille University Hospital Center | Bens G.,Porte Madeleine Hospital | And 2 more authors.
European Journal of Dermatology | Year: 2012

Background: Merkel cell carcinoma (MCC) is a rare neuroendocrine tumor of the skin. The epidemiological factors strongly associated with this tumor are: age over 65 years, fair skin, chronic sun exposure and immune suppression. Data are sparse in the literature and many questions remain unanswered regarding the diagnosis and treatment of this tumor. Objective: To provide clinical practice guidelines for the diagnosis and treatment of MCC. Method: The literature data were analyzed and the current American and German practice guidelines were compared. Consensus items between these two guidelines were adopted as recommendations. Regarding discordant points, a formalized expert consensus process was devised. The guidelines were then written up by an editorial panel and validated by the Cutaneous Oncology Group of the French Society of Dermatology. Results: The guidelines were drawn up according to three levels of scientific evidence: (a) complete agreement between the American and German guidelines; (b) the results of the formalized expert consensus process; and (c) the expert opinion of the steering group, based on analysis of the available evidence. The guidelines presented here are up-to-date recommendations on the clinical and pathological procedures for MCC diagnosis, staging, surgical treatment, sentinel node biopsy, radiotherapy and follow-up. Conclusion: These guidelines for diagnosis and treatment of MCC should standardize MCC management, which may not be optimal in France today.


PubMed | University Hospital of Nice, Klinikum Vest GmbH, University of Munster, Galderma R&D and 15 more.
Type: Clinical Trial, Phase III | Journal: Journal of the European Academy of Dermatology and Venereology : JEADV | Year: 2016

Unmet needs exist in actinic keratosis (AK) treatment. Daylight photodynamic therapy (DL-PDT) has shown good efficacy and safety results compared to conventional PDT (c-PDT) in a recent Phase III multi-centre randomised controlled trial in Australia among 100 subjects with AKs.Demonstrate non-inferior efficacy and superior safety of DL-PDT compared to c-PDT in treating multiple mild and/or moderate facial/scalp AKs.Phase III, 12 week, multi-centre, randomised, investigator-blinded, controlled, intra-individual study conducted at different latitudes in Europe. AKs of adult subjects were treated once with methyl aminolevulinate (MAL) DL-PDT on one side of the face and MAL c-PDT contralaterally. Endpoints for DL-PDT concerned efficacy (non-inferiority regarding complete lesion response at week 12) and safety (superiority regarding subjects assessment of pain after treatment, on an 11-point numeric rating scale). Safety evaluation also included incidence of adverse events. Subject satisfaction was described using a questionnaire at baseline and last visit.At week 12, the total lesion complete response rate with DL-PDT was similar (non-inferior) to c-PDT (70% vs. 74%, respectively; 95% CI [-9.5; 2.4] in PP analysis, confirmed in ITT analysis). In addition, efficacy of DL-PDT was demonstrated regardless of weather conditions (sunny or cloudy). DL-PDT was nearly painless compared to c-PDT (0.7 vs. 4.4, respectively; P < 0.001), better tolerated and resulted in higher subject satisfaction.DL-PDT in comparison with c-PDT was as effective, better tolerated and nearly painless with high patient satisfaction, and may be considered a treatment of choice to meet needs of patients with mild or moderate facial/scalp AKs.


PubMed | University of Würzburg, Montpellier University, Fraunhofer Institute for Interfacial Engineering and Biotechnology, Galway University and 8 more.
Type: Clinical Trial, Phase I | Journal: Stem cells translational medicine | Year: 2016

: Osteoarthritis (OA) is the most widespread musculoskeletal disorder in adults. It leads to cartilage damage associated with subchondral bone changes and synovial inflammation, causing pain and disability. The present study aimed at evaluating the safety of a dose-escalation protocol of intra-articular injected adipose-derived stromal cells (ASCs) in patients with knee OA, as well as clinical efficacy as secondary endpoint. A bicentric, uncontrolled, open phase I clinical trial was conducted in France and Germany with regulatory agency approval for ASC expansion procedure in both countries. From April 2012 to December 2013, 18 consecutive patients with symptomatic and severe knee OA were treated with a single intra-articular injection of autologous ASCs. The study design consisted of three consecutive cohorts (six patients each) with dose escalation: low dose (2 10(6) cells), medium dose (10 10(6)), and high dose (50 10(6)). The primary outcome parameter was safety evaluated by recording adverse events throughout the trial, and secondary parameters were pain and function subscales of the Western Ontario and McMaster Universities Arthritis Index. After 6 months of follow-up, the procedure was found to be safe, and no serious adverse events were reported. Four patients experienced transient knee joint pain and swelling after local injection. Interestingly, patients treated with low-dose ASCs experienced significant improvements in pain levels and function compared with baseline. Our data suggest that the intra-articular injection of ASCs is a safe therapeutic alternative to treat severe knee OA patients. A placebo-controlled double-blind phase IIb study is being initiated to assess clinical and structural efficacy.Although this phase I study included a limited number of patients without a placebo arm, it showed that local injection of autologous adipose-derived stem cells was safe and well tolerated in patients with knee osteoarthritis. This study also provides encouraging preliminary evidence of efficacy. Larger and controlled long-term studies are now mandatory to confirm whether this new strategy of cell therapy can improve pain and induce structural benefit in osteoarthritis.


Pfeiffer C.,French National Center for Scientific Research | Pfeiffer C.,Hospital Saint Eloi | Mathieu-Dupas E.,French National Center for Scientific Research | Logghe P.,French National Center for Scientific Research | And 9 more authors.
Thrombosis Research | Year: 2016

While the immune response to hemophilic factors in hemophilia has been widely studied, little is known about the development of anti-Factor VII (FVII) antibodies in FVII deficiency. We developed a robust technique based on the x-MAP technology to detect the presence of antibodies against FVII and characterize their isotype and validated this method using blood samples from 100 patients with FVII deficiency (median FVII clotting activity [FVII:C]: 6%) and 95 healthy controls. Anti-FVII antibodies were detected in patients but also in some controls, although the concentration of total immunoglobulin G (IgGt) and IgG1 and IgG4 subclasses was significantly different between groups. The IgG1 subclass concentrations remained significantly different also when only untreated patients were compared with controls. This difference could partially be related to the F7 genotype, particularly in patients harboring the p.Arg139Gln mutation. This x-MAP-based method might be useful for assessing the immunogenicity of novel FVII compounds and of activated FVII (FVIIa) concentrates. Further prospective studies are needed to better understand the clinical relevance of these antibodies in the management of patients with FVII deficiency. © 2016 Elsevier Ltd. All rights reserved.


Bai Q.,French Institute of Health and Medical Research | Bai Q.,Montpellier University | Bai Q.,Hospital Saint Eloi | Bai Q.,Chongqing Medical University | And 14 more authors.
Stem Cells and Development | Year: 2015

Simplified culture conditions are essential for large-scale drug screening and medical applications of human pluripotent stem cells (hPSCs). However, hPSCs [ie, human embryonic stem cells (hESCs), and human induced pluripotent stem cells (iPSCs) are prone to genomic instability, a phenomenon that is highly influenced by the culture conditions. Enzymatic dissociation, a cornerstone of large-scale hPSC culture systems, has been reported to be deleterious, but the extent and the timeline of the genomic alterations induced by this passaging technique are still unclear. We prospectively monitored three hESC lines that were initially derived and cultured on human feeders and passaged mechanically before switching to enzymatic single-cell passaging. We show that karyotype abnormalities and copy number variations are not restricted to long-term culture, but can occur very rapidly, within five passages after switching hESCs to enzymatic dissociation. Subchromosomal abnormalities preceded or accompanied karyotype abnormalities and were associated with increased occurrence of DNA double-strand breaks. Our results indicate that enzymatic single-cell passaging can be highly deleterious to the hPSC genome, even when used only for a limited period of time. Moreover, hPSC culture techniques should be reappraised by complementing the routine karyotype analysis with more sensitive techniques, such as microarrays, to detect subchromosomal abnormalities. Copyright 2015, Mary Ann Liebert, Inc.


Gondeau C.,Hospital Saint Eloi | Gondeau C.,Montpellier University | Pageaux G.P.,Hospital Saint Eloi | Larrey D.,Hospital Saint Eloi | Larrey D.,Montpellier University
World Journal of Gastroenterology | Year: 2015

Hepatitis C virus (HCV) infection is one of the most common causes of chronic liver disease and the main indication for liver transplantation worldwide. As promising specific treatments have been introduced for genotype 1, clinicians and researchers are now focusing on patients infected by non-genotype 1 HCV, particularly genotype 3. Indeed, in the golden era of direct-acting antiviral drugs, genotype 3 infections are no longer considered as easy to treat and are associated with higher risk of developing severe liver injuries, such as cirrhosis and hepatocellular carcinoma. Moreover, HCV genotype 3 accounts for 40% of all HCV infections in Asia and is the most frequent genotype among HCV-positive injecting drug users in several countries. Here, we review recent data on HCV genotype 3 infection/treatment, including clinical aspects and the underlying genotype-specific molecular mechanisms. © 2015 Baishideng Publishing Group Inc. All rights reserved.


PubMed | Hospital Saint Eloi
Type: Comparative Study | Journal: Journal of wound care | Year: 2012

To investigate the efficacy and safety of hyaluronic acid in the local treatment of leg ulcers of venous or mixed aetiology, compared with a neutral vehicle.A 60-day double-blind, randomised, multicentre, controlled superiority trial. The primary endpoint was the percentage wound size reduction after 45 days of treatment. Secondary endpoints included pain intensity, rate of complete ulcer healing, and aspect of the wound (percentage of necrotic, fibrinous or granulation tissue) and of the peri-ulcer skin.A total of 101 patients were randomised and analysed in the intention-to-treat (ITT) population (50 in the hyaluronic acid; 51 in the control group). Seventy-five patients were considered in the per protocol (PP) population (38 vs 37, respectively). At day 45, the percentage of ulcer surface reduction was significantly greater in the hyaluronic acid treatment group (39 6%) compared with the neutral vehicle (control) group (5 9%) (p=0.002). A similar result was obtained at day 15, day 30 and day 60. From day 0 to day 45, pain intensity (VA S) decreased by mean 9.8 3.5mm in the hyaluronic acid group, but slightly increased by 0.8 3.2mm in the control group (p=0.029). Burden of pain, as estimated by the area under the curve of daily pain (from day 0 to day 60), was significantly lower in the hyaluronic acid group (121.9 20.7mm2) than in the control group (207.4 32.9mm2; p=0.028). Other secondary endpoints (rate of complete healing, characteristics of the wound and peri-ulcer skin) were not significantly different between the two groups. Treatments were well tolerated and adverse events were comparable between the two groups in terms of their frequency, relationship to treatment and severity.Hyaluronic acid cream was significantly more effective than the neutral vehicle in the local treatment of leg ulcers of venous or mixed aetiology, in terms of wound size reduction and reducing the burden of pain, with a good safety profile.


PubMed | Hospital Saint Eloi
Type: Journal Article | Journal: World journal of gastroenterology | Year: 2015

Hepatitis C virus (HCV) infection is one of the most common causes of chronic liver disease and the main indication for liver transplantation worldwide. As promising specific treatments have been introduced for genotype 1, clinicians and researchers are now focusing on patients infected by non-genotype 1 HCV, particularly genotype 3. Indeed, in the golden era of direct-acting antiviral drugs, genotype 3 infections are no longer considered as easy to treat and are associated with higher risk of developing severe liver injuries, such as cirrhosis and hepatocellular carcinoma. Moreover, HCV genotype 3 accounts for 40% of all HCV infections in Asia and is the most frequent genotype among HCV-positive injecting drug users in several countries. Here, we review recent data on HCV genotype 3 infection/treatment, including clinical aspects and the underlying genotype-specific molecular mechanisms.

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