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排序方式: 共有67条查询结果,搜索用时 31 毫秒
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Robert S. Kirsner MD PhD Wolfgang Vanscheidt MD David H. Keast MD John C. Lantis MD II Cyaandi R. Dove DPM Shawn M. Cazzell DPM Mher Vartivarian DPM Matthias Augustin MD William A. Marston MD Nicholas D. McCoy BS D. Innes Cargill PhD Tommy D. Lee MSHS Jaime E. Dickerson PhD Jr Herbert B. Slade MD for the HP‐ Study Group 《Wound repair and regeneration》2016,24(5):894-903
In 2012 we reported promising results from a phase 2 clinical trial of HP802‐247, a novel spray‐applied investigational treatment for chronic venous leg ulcers consisting of human, allogeneic fibroblasts and keratinocytes. We now describe phase 3 clinical testing of HP802‐247, its failure to detect efficacy, and subsequent investigation into the root causes of the failure. Two randomized, controlled trials enrolled a total of 673 adult outpatients at 96 centers in North America and Europe. The primary endpoint was the proportion of ulcers with confirmed closure at the end of 12 weeks of treatment. An investigation into the root cause for the failure of HP802‐247 to show efficacy in these two phase 3 trials was initiated immediately following the initial review of the North American trial results. Four hundred twenty‐one patients were enrolled in the North American (HP802‐247, 211; Vehicle 210) and 252 in the European (HP802‐247, 131; Vehicle 121) trials. No difference in proportion of closed ulcers at week 12 was observed between treatment groups for either the North American (HP802‐247, 61.1%; Vehicle 60.0%; p = 0.5896) or the European (HP802‐247, 47.0%; Vehicle 50.0%; p = 0.5348) trials. Thorough investigation found no likelihood that design or execution of the trials contributed to the failure. Variability over time during the trials in the clinical response implicated the quality of the cells comprising HP802‐247. Concordance between the two separate, randomized, controlled trials with distinct, nonoverlapping investigative sites and independent monitoring teams renders the possibility of a Type II error vanishingly small and provides strong credibility for the unexpected lack of efficacy observed. The most likely causative factors for the efficacy failure in phase 3 was phenotypic change in the cells (primarily keratinocytes) leading to batch to batch variability due to the age of the cell banks. 相似文献
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Erhan Akinci Max-Oskar Wieser Simon Vanscheidt Shirin Diop Vera Flasbeck Burhan Akinci Cora Stiller Georg Juckel Paraskevi Mavrogiorgou 《Psychiatry investigation》2022,19(3):178
ObjectiveDespite the numerous findings on the altered emotion recognition and dysfunctional social interaction behavior of depressive patients, a lot of the relationships are not clearly clarified.MethodsIn this pilot study, 20 depressive patients (mean±SD, 38.4±14.2) and 20 healthy subjects (mean±SD, 38.9±15.3) (each in dyads) were videographed. We then analyzed their social interaction behavior and emotion processing in terms of emotion recognition, their own emotional experience, and the expression of emotions under the conditions of a semi-structured experimental paradigm. ResultsPatients showed more significant impairment regarding the dimensions of social interaction behavior (i.e., attention, interest, and activity) and their interaction behavior was characterized by neutral affectivity, silence, and avoidance of direct eye contact. This interactive behavioral style was statistically related to depressive psychopathology. There were no differences concerning emotion recognition. ConclusionImpairments of non-verbal and verbal social interaction behavior of depressive patients seem to be less associated with disturbances of basic skills of emotion recognition. 相似文献
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Nitrazine yellow test has proved successful in determining toxic degenerative hand eczema. Additionally, it may be regarded as helpful in the quantitative registration of kinetic data on epidermal wound healing. 相似文献
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M. Peschen Harald Grenz Beate Brand-Saberi Maria Bunaes Jan C. Simon Erwin Schöpf Wolfgang Vanscheidt 《Archives of dermatological research》1998,290(6):291-297
Abstract Growth factors produced by a variety of cells act as signalling peptides through specific cell surface receptor pathways.
Functions such as cell proliferation, migration and differentiation have been assigned to each of them. Here, we report alterations
of platelet-derived growth factor receptor alpha (PDGFR-α) and beta (PDGFR-β) and vascular endothelial growth factor (VEGF)
expression patterns in the progressive clinical stages of chronic venous insufficiency (CVI). A total of 30 punch biopsies
were taken from patients with CVI, and VEGF and PDGFR were detected by indirect immunofluorescence and immunoperoxidase techniques.
PDGFR-α and PDGFR-β expression was strongly increased in endothelial cells of capillaries, pericapillary cells and connective
tissue cells in the stroma of the skin of venous eczema and venous leg ulcer patients, and to a smaller extend in the dermis
of those with lipodermatosclerosis. VEGF staining showed a similar expression pattern in the progressive CVI stages. However,
staining of vessels in particular might simply reflect binding of VEGF, secreted by keratinocytes or fibroblasts, to its receptors.
Growth factor and receptor expression in specimens from telangiectases and reticular veins, and from pigmented areas, resembled
that of normal skin. We conclude that PDGFR-α, PDGFR-β and VEGF play an important role in mediating inflammation and epithelial
hyperproliferation in venous eczema, inducing connective tissue sclerosis in lipodermatosclerosis, and causing the reduced
reepithelialization tendency in venous ulcers. We speculate that endothelial proliferation with chronic venous hypertension
might be mediated by these growth factors.
Received: 1 April 1997 相似文献
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From 1978 to 1982 1 364 patients received an aorto-coronary vein graft, reoperations not included. Immediately after the operation the surgeon had to document the intraoperatively taken findings like diameter and quality of the coronary arteries, diameter and quality of the veins, quality of the aorta, bypass-flow according to a standardized protocol. 806 patients could be coronarographied 8 weeks after. The influence of intraoperative findings on the early occlusion of aorto-coronary vein grafts is discussed. 相似文献