European CHMP to discuss licensing application for defibrotide to treat and prevent hepatic veno-occlusive disease

Source: GlobeNewswire Area: News Gentium S.p.A has announced that its Marketing Authorisation Application (MAA) for defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy, will be on the agenda for discussion at the European Medicines Agency's Committee for Medicinal Products for Human Use meetings scheduled to be held on February 18-21, 2013.   Certain high-dose conditioning regimens used as part of stem cell transplantation can damage the lining cells of hepatic blood vessels and result in VOD, a blockage of the small veins in the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs.   At present there is no approved agent for the treatment or prevention of VOD in the US or EU.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news

Related Links:

Fight Aging! provides a weekly digest of news and commentary for thousands of subscribers interested in the latest longevity science: progress towards the medical control of aging in order to prevent age-related frailty, suffering, and disease, as well as improvements in the present understanding of what works and what doesn't work when it comes to extending healthy life. Expect to see summaries of recent advances in medical research, news from the scientific community, advocacy and fundraising initiatives to help speed work on the repair and reversal of aging, links to online resources, and much more. This content is...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
In conclusion, a debate exists on whether aging is a disease in itself. Some authors suggest that physiological aging (or senescence) is not really distinguishable from pathology, while others argue that aging is different from age-related diseases and other pathologies. It is interesting to stress that the answer to this question has important theoretical and practical consequences, taking into account that various strategies capable of setting back the aging clock are emerging. The most relevant consequence is that, if we agree that aging is equal to disease, all human beings have to be considered as patients to be treat...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
The week of April 23-27 has been designated as National Pediatric Transplant Week.  This week is to bring attention to the great need for organ donations and to honor  donors and their families whose incredibly selfless gift has given someone the gift of life.While most of us will never experience the need for a transplant, there are many of us who know someone who has a debilitating condition such as kidney dialysis that are in need of a transplant.Right now there are almost 2,000 children on the national transplant list.  Those needing hearts, lungs, eyes, tissue, liver, kidney, or some other body part are...
Source: Pediatric Health Associates - Category: Pediatrics Tags: Volunteer Opportunities Source Type: news
This study demonstrates that small peptide domains derived from native protein amelogenin can be utilized to construct a mineral layer on damaged human enamel in vitro. Six groups were prepared to carry out remineralization on artificially created lesions on enamel: (1) no treatment, (2) Ca2+ and PO43- only, (3) 1100 ppm fluoride (F), (4) 20 000 ppm F, (5) 1100 ppm F and peptide, and (6) peptide alone. While the 1100 ppm F sample (indicative of common F content of toothpaste for homecare) did not deliver F to the thinly deposited mineral layer, high F test sample (indicative of clinical varnish treatment) formed mainly C...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
In conclusion, senescence of vascular cells promotes the development of age-related disorders, including heart failure, diabetes, and atherosclerotic diseases, while suppression of vascular cell senescence ameliorates phenotypic features of aging in various models. Recent findings have indicated that specific depletion of senescent cells reverses age-related changes. Although the biological networks contributing to maintenance of homeostasis are extremely complex, it seems reasonable to explore senolytic agents that can act on specific cellular components or tissues. Several clinical trials of senolytic agents are currentl...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
Making human tissue in a lab has always been more sci-fi than sci-fact, but powerful genetic technologies may change that soon. For the most part, the only way to replace diseased or failing hearts, lungs, kidneys and livers is with donor organs. Even then, many people struggle to find a good biological match with a donor, and 8,000 die each year in the U.S. while waiting for an organ. In one promising solution to the shortage, researchers have been putting a new DNA editing tool called CRISPR through rigorous tests in organ regeneration. Last August, a group of scientists led by George Church, professor of genetics at Har...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized healthytime Longevity organ transplants Source Type: news
In conclusion, most experimental data on immune changes with aging show a decline in many immune parameters when compared to young healthy subjects. The bulk of these changes is termed immunosenescence. Immunosenescence has been considered for some time as detrimental because it often leads to subclinical accumulation of pro-inflammatory factors and inflammaging. Together, immunosenescence and inflammaging are suggested to stand at the origin of most of the diseases of the elderly, such as infections, cancer, autoimmune disorders, and chronic inflammatory diseases. However, an increasing number of gerontologists have chall...
Source: Fight Aging! - Category: Research Authors: Tags: Newsletters Source Type: blogs
Background: Veno-occlusive disease (VOD) can be a life-threatening complication of allogeneic and autologous hematopoietic stem cell transplant (HSCT). The pathologic process affects multiple organs including liver, lung, kidney and the coagulation system. The severity of the coagulopathy varies considerably between patients. Few data exist on the best methods to correct coagulation parameters and reduce the risk of bleeding in patients with VOD. This is critically important since the contraindication for defibrotide treatment includes uncontrolled bleeding.
Source: Biology of Blood and Marrow Transplantation - Category: Hematology Authors: Source Type: research
CONCLUSION: Total body irradiation using helical TomoTherapy® is feasible. It allows a very good homogeneity of dose and conformity with an acceptable tolerance. It could deliver higher doses to sites at high risk of recurrence (bone marrow, sanctuary sites), while sparing major normal organs like lungs, liver, and kidneys. This reduction of dose could lead to reduced severity and frequency of late complications. PMID: 29395854 [PubMed - as supplied by publisher]
Source: Cancer Radiotherapie - Category: Cancer & Oncology Authors: Tags: Cancer Radiother Source Type: research
In January, 2018, Academic Press published my bookPrecision Medicine and the Reinvention of Human Disease. This book has an excellent " look inside " at itsGoogle book site, which includes the Table of Contents. In addition, I thought it might be helpful to see the topics listed in the Book's index. Note that page numbers followed by f indicate figures, t indicate tables, and ge indicate glossary terms.AAbandonware, 270, 310geAb initio, 34, 48ge, 108geABL (abelson leukemia) gene, 28, 58ge, 95 –97Absidia corymbifera, 218Acanthameoba, 213Acanthosis nigricans, 144geAchondroplasia, 74, 143ge, 354geAcne, 54ge, 1...
Source: Specified Life - Category: Information Technology Tags: index jules berman jules j berman precision medicine Source Type: blogs
More News: Children | Drugs & Pharmacology | European Medicines Agency (EMA) | Kidney Transplant | Kidney Transplantation | Liver | Liver Transplant | Lung Transplant | Marketing | Stem Cell Therapy | Stem Cells | Transplants | Urology & Nephrology