"Birch bark"

Birch bark extract for treating epidermolysis bullosa Birch bark extract for treating epidermolysis bullosa Highly specialised technologies guidance Published: 20 September 2023 www.nice.org.uk/guidance/hst28 © NICE 2023. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and-conditions#notice-of-rights).Your responsibility The recommendations in this guidance and to reduce health inequalities. Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible. Birch bark extract for treating epidermolysis bullosa (HST28)© NICE 2023. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk

Birch bark extract (Filsuvez) - treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) 1 Published 08 July 2024 1 SMC2651 birch bark extract gel (Filsuvez®) Chiesi Limited 07 June 2024 The Scottish Medicines Consortium (SMC) has completed its initial assessment of the evidence for the above product using the ultra-orphan framework: Indication , and squamous cell carcinoma). These all can carry considerable morbidity and increased mortality risk. • In a double-blind, randomised, phase III study, birch bark extract gel led to quicker wound healing than a control gel. Results may also suggest potential improvements in the frequency of dressing changes, and the amount of affected skin. • The effect of birch bark extract on other relevant outcomes

Birch bark extract (Filsuvez) - epidermolysis bullosa Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged. EMA/239723/2022 EMEA/H/C/005035 Filsuvez (birch bark extract) An overview of Filsuvez and why it is authorised in the EU What is Filsuvez and what is it used for? Filsuvez is a medicine that is used in adults and children aged 6 months or older with epidermolysis bullosa (EB). EB is an inherited disease of the skin that makes the skin very fragile

Long-term safety and efficacy of Oleogel-S10 (birch bark extract) in epidermolysis bullosa: 24-month results from the Phase III EASE Study. Epidermolysis bullosa (EB) is a group of rare, severe, genetic disorders characterised by persistent skin fragility and open wounds. EB manifests as cutaneous and mucosal blistering, erosions and impaired wound healing. To determine the long-term efficacy , tolerability and safety of Oleogel-S10 (birch bark extract) in dystrophic (DEB) and junctional (JEB) EB in the 24-months open-label phase (OLP) of the EASE study. EASE was a double-blind, randomised, controlled, phase III study consisting of two phases: a 90-day double-blind phase (DBP), and a 24-month OLP. Patients from both former treatment groups in the DBP entered the single-arm OLP (n = 205). Patients

Birch Bark Extract: A Review in Epidermolysis Bullosa. Birch bark extract (Filsuvez; also known as the developmental name Oleogel-S10), a topical gel consisting of 10% dry birch bark extract and 90% sunflower oil, is the first therapy approved in the EU and UK for the treatment of partial thickness wounds associated with dystrophic and junctional epidermolysis bullosa (EB) in patients aged ≥ 6 months old. In the pivotal double-blind, randomized, vehicle-controlled, phase III EASE trial in patients with EB, the primary endpoint was met, in which birch bark extract relative to control gel significantly increased the proportion of patients with first complete target wound closure within 45 days. Moreover, patients treated with birch bark extract demonstrated several other positive findings

Novel compounds discovery approach based on UPLC-QTOF-MS/MS chemical profile reveals birch bark extract anti-inflammatory, -oxidative, and -proliferative effects. Betula pendula subsp. Mandshurica (Regel) Ashburner & McAll. Cortex (birch bark) is a globally traditional medicine for treating multiple inflammatory diseases. Its records are included in the Compendium of Materia Medica and other ancient medical literatures. However, uncovering its chemical profile and exploring novel biologically active compounds from birch bark remains a significant challenge. To uncover the anti-inflammatory, -oxidative, and -proliferative mechanisms and potentially effective compounds of birch bark extract by combing chemical profiling, isolation, identification, together with in vivo, in vitro, and silico

Episalvan - birch bark extract 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520 Send a question via our website www.ema.europa.eu/conta t 19 November 2015 EMA/833320/2015 Committee for Medicinal Products for Human Use (CHMP) Assessment report Episalvan International non -proprietary name: birch bark extract Procedure No. EMEA/H/C/003938/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/833320/2015 Page 2/104 Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier

Experimental methods for the Palaeolithic dry distillation of birch bark: implications for the origin and development of Neandertal adhesive technology The destructive distillation of birch bark to produce tar has recently featured in debates about the technological and cognitive abilities of Neandertals and modern humans. The abilities to precisely control fire temperatures and to manipulate adhesive properties are believed to require advanced mental traits. However, the significance given to adhesive technology in these debates has quickly outgrown our understanding of birch bark tar and its manufacture using aceramic techniques. In this paper, we detail three experimental methods of Palaeolithic tar production ranging from simple to complex. We recorded the fuel, time, materials

Influence of the Oil Phase and Topical Formulation on the Wound Healing Ability of a Birch Bark Dry Extract Triterpenes from the outer bark of birch are known for various pharmacological effects including enhanced wound healing (WH). A birch bark dry extract (TE) obtained by accelerated solvent extraction showed the ability to form oleogels when it is suspended in oils. Consistency

Effective Method of Purification of Betulin from Birch Bark: The Importance of Its Purity for Scientific and Medicinal Use A new and relatively simple method for purification of betulin from birch bark extract was developed in this study. Its five purification steps are based on the differential solubility of extract components in various solvents and their crystallization and/or precipitation , on their affinity for Ca(OH)2 in ethanol, and on the affinity of some impurities for silica gel in chloroform. In addition, all used solvents can be simply recycled. Betulin of more than 99% purity can be prepared by this method with minimal costs. Various observations including crystallization of betulin, changes in crystals during heating, and attempt of localization of betulin in outer birch bark are also

Evaluation and differentiation of the Betulaceae birch bark species and their bioactive triterpene content using analytical FT-vibrational spectroscopy and GC-MS Aiming to obtain the highest triterpene content in the extraction products, nine bark samples from the forest abundant flora of Apuseni Mountains, Romania were Raman spectroscopically evaluated. Three different natural extracts from Betula pendula Roth birch bark have been obtained and characterized using Fourier transform vibrational spectra. This study shows that principal components of the birch tree extract can be rapidly recognized and differentiated based on their vibrational fingerprint band shape and intensity. The vibrational spectroscopy results are supported by the GC-MS data. Based on IR and Raman analysis, one can

Differences in birch tar composition are explained by adhesive function in the central European Iron Age. Birch bark tar is the most widely documented adhesive in prehistoric Europe. More recent periods attest to a diversification in terms of the materials used as adhesives and their application. Some studies have shown that conifer resins and beeswax were added to produce compound adhesives contents, and adhesive lumps. Our findings show that, even during the Iron Age in north-eastern France, birch bark tar is one of the best-preserved adhesive substances, used for at least 400 years. To a lesser extent, Pinaceae resin and beeswax were also identified. Through statistical analyses, we show that molecular composition differs in samples, correlating with adhesive function. This has

The antioxidant betulinic acid enhances porcine oocyte maturation through Nrf2/Keap1 signaling pathway modulation. During in vitro maturation, excess levels of reactive oxygen species (ROS) are a major cause of developmental defects in embryos. Betulinic acid (BA) is a naturally produced antioxidant in white birch bark. Recent studies have shown that BA exhibits antioxidant properties in various

Oleogel-S10 Phase 3 study "EASE" for epidermolysis bullosa: study design and rationale. Epidermolysis bullosa (EB) is a group of rare, genetic diseases that affect the integrity of epithelial tissues, most notably the skin. Patients experience recurrent skin wounding, with severity depending on type, sub-type, and mutation. Oleogel-S10, a formulation of birch bark extract, has demonstrated

molecules. The aim of this study is to compare in-vitro and ex-vivo test systems for their usability for early drug screening and to investigate the efficacy of a birch bark triterpene extract (TE) that has been proven ex-vivo and clinically to accelerate non-diabetic wound healing (WH), in a diabetic context. We investigated in-vitro models for diabetic WH, i.e. scratch assays with human keratinocytes

) or standard of care plus TBG consisting of 10% birch bark extract and 90% sunflower oil (Episalvan, Birken AG, Niefern-Oeschelbronn, Germany). The primary efficacy assessment was the intra-individual difference in time to wound closure assessed from digital photographs by three blinded experts. A total of 219 patients were included and treated in the two trials. Wounds closed faster with TBG than without

OLEOGEL-S10 TO ACCELERATE HEALING OF DONOR SITES: MONOCENTRIC RESULTS OF PHASE III CLINICAL TRIAL. Oleogel-S10, an ointment containing betulin-rich triterpene dry extract from birch bark was tested in an open, blindly evaluated, prospective, controlled, randomized multicentre study to improve wound healing in donor sites. The primary endpoint was time to wound closure, and secondary endpoints

Betulin-Based Oleogel to Improve Wound Healing in Dystrophic Epidermolysis Bullosa: A Prospective Controlled Proof-of-Concept Study Skin fragility and recurrent wounds are hallmarks of hereditary epidermolysis bullosa (EB). Treatment options to accelerate wound healing are urgently needed. Oleogel-S10 contains a betulin-rich triterpene extract from birch bark. In this study, we tested the wound

of hafting technology is from the site of Campitello Quarry in Tuscany (Central Italy) where birch-bark tar, found on the proximal part of two flint flakes, is dated to the end of MIS 7. Nevertheless, a peculiar feature of the Middle Paleolithic at Torre in Pietra is the continuous presence of small tool blanks on pebbles and cores and on thick flake albeit at a much lower frequency than in the older