Artificial liver

In a major move towards the development of an artificial liver, following favourable new research outcomes, Boston, United States-based HepaLife Technologies announced in mid-February they would accelerate plans for the development of a bioreactor system for a first-of-its-kind artificial liver device. The company has appointed Berlin, Germany-based Stem Cell Systems to assist with the bioreactor system.

HepaLife announced that in ongoing research, scientists have demonstrated that the their patented PICM-19 cells have unique characteristics distinct from other cells, and are able to successfully mimic the human liver’s response in several important ways. Among other research outcomes, important liver-specific activity levels in the PICM- 19 cells were up to three times higher than those found in human-derived cell lines frequently used for similar applications.

This functionality is crucial since, according to researchers, the most vital component in an artificial liver device is not the mechanical hardware, but rather the biological cells inside the device which are responsible for truly replicating and performing the functions of the human liver.

“Our cell line sets us apart from anyone else,” explained Frank Menzler, president and CEO of HepaLife Technologies. “While other cells often develop cancers, lose their ability to function, or simply die, our patented PICM-19 cells have successfully retained their liver-like functions, surpassed highly demanding development objectives, and outperformed other cell lines for use in artificial liver devices.

“As a result, we can now confidently advance our efforts to incorporate these cells into the first-of-its-kind artificial liver device through the development of a bioreactor system, a mechanical component which holds and grows biological cells,” he said.


Autism gene

A gene called SHANK3 is mutated in a small number of individuals with autism, providing new insight into the biological basis of this disease, according to a study published in the January issue of Nature Genetics.

Autism spectrum disorders (ASD), which comprise a range of disorders affecting social interaction and communication, affect 6 out of every 1,000 children. Approximately 3-6% of cases are caused by chromosomal rearrangements, with a small region on chromosome 22 affected frequently in individuals with cognitive deficits accompanied by autistic behaviour. This region contains three genes, one of which – SHANK3 – is a good candidate to be associated with autism given its expression in neuronal synapses.

Thomas Bourgeron and colleagues sequenced SHANK3 in more than 200 individuals with ASD, and found mutations in 3 families. An individual in one family had a significant deletion in the gene, while two brothers in a second family had a smaller deletion. In the third family, a girl with autism had a deletion in SHANK3, while her brother, affected with a mild form of autism called Asperger syndrome, had an additional copy of SHANK3.

The protein encoded by SHANK3 interacts with other proteins called neuroligins, which have a role in neuronal signaling. Mutations in two of the genes encoding neuroligins have previously been found in a small number of individuals with autism, suggesting that neuroligin function should receive increased attention in the search for the biological basis of ASD.


Body parts on the Net

British media report that the sale of body parts on the Internet is a growing phenomenon, although it is illegal in the United Kingdom.

According to a BBC News report people are selling kidneys, parts of their liver, and the corneas from their eyes, online to raise money.

The British Transplantation Society condemned the practice, saying it considered the sale of organs for personal gain unethical. The report quoted a surgeon who said the sale of corneas, which would blind donors in the eye from which the cornea was taken showed the lengths that some people were prepared to go to for money.

The surgeon warned both donors and recipients of the dangers involved in organ transplantation, saying in the UK there was a one 3,000 chance of a person donating a kidney dying after the operation, and a one in 200 chance after donating a section of liver.


Drug depot in a tooth

Regular pill-taking could soon to become a thing of the past. Scientists in an EU consortium are developing a new prosthesis that releases the correct dosage of the required medicine on a continuous basis. This will help to avoid the peak concentrations that occur on taking pills, aggravating the side effects. What makes the Intellidrug prosthesis unique is that, unlike existing drug prostheses and implants, it is small enough to fit into two artificial molars. Inside the patient’s mouth, it is readily accessible and can easily be maintained and refilled.

“The dental prosthesis consists of a drug-filled reservoir, a valve, two sensors and several electronic components,” explained Dr Oliver Scholz of the Fraunhofer Institute for Biomedical Engineering IBMT in St Ingbert, where the sensors and electronics were developed. “Saliva enters the reservoir via a membrane, dissolves part of the solid drug and flows through a small duct into the mouth cavity, where it is absorbed by the mucous membranes in the patient’s cheeks.”

The duct is fitted with two sensors that monitor the amount of medicine being released into the body. One is a flow sensor that measures the volume of liquid entering the mouth via the duct, while the other measures the concentration of the agent contained in the liquid. Based on the measurement results, the electronic circuit either opens or closes a valve at the end of the duct to control the dosage. If the agent has been used up, the electronic system alerts the patient via a remote control, which permits wireless operation of Intellidrug, and can be used by the patient or doctor to set the dosage required.

Intellidrug is to undergo clinical testing this year.


GE buys Abbots

General Electric announced in late January that the company had purchased Abbott’s primary in vitro diagnostics businesses and Abbott Point-of-Care diagnostics business for US$8.13 billion in cash.

GE says the addition of two of Abbott’s core laboratory diagnostics businesses will broaden GE Healthcare’s diagnostic offerings and reflects the company’s strategy to combine early diagnosis with information technology to enable a new “early health” model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention.

Abbott is a world leader in immunoassays and blood screening. The company offers a broad range of medical tests and diagnostic instrument systems which are used worldwide by hospitals, laboratories, blood banks, and physician offices. The deal is subject to regulatory approval.


Women and heart disease

Scientists at United Statesbased Children’s Hospital Oakland Research Institute (CHORI), the University of Iowa and Roche Molecular Systems are the first to identify a new gene variant that makes women more susceptible to developing heart disease. The affected gene is called Leukotriene C4 Synthase (LTC4S) and its variant could be identified through a genetic test at birth. The use of such a test would allow physicians to initiate preventative treatments to reduce or even eliminate the risk of heart disease in those women possessing the variant gene.

The study is published in the February issue of the American Heart Association journal Arteriosclerosis, Thrombosis, and Vascular Biology. The study began in 1971 with 11,377 children in Muscatine, Iowa. During the study, researchers periodically evaluated the participants’ risks of developing heart disease starting in their teens and into their 40’s. Their weight, height, blood pressure, cholesterol and other health factors and risks were recorded between 1971 and 1996.

Scientists at CHORI were responsible for genotyping DNA samples and drawing the study’s conclusions. They hypothesised that inflammation was an important predictor for the development of heart disease. Inflammation is necessary to repair and heal nicks to the lining of blood vessels, which occur daily.

The variant form of the LTC4S gene however, leads to an excessive inflammatory response at the site of blood vessel injury. As a result, people who inherit this gene variant don’t repair damage to their blood vessels as well as others. Until now, the LTC4S gene variant was only known to cause asthma.

“This is the first direct evidence that a gene known to be linked to asthma is also tied to adult heart disease,” said Edward Lammer, MD, geneticist at Children’s Hospital Oakland Research Institute. “Our work is significant because we made allowances for other risk factors such as smoking, cholesterol and blood pressure levels.

Consequently, we believe that the risk is genetic and not significantly influenced by a person’s environment.” These research results add to growing evidence suggesting that inflammatory responses are very important for development of coronary artery disease and stroke. Consequently, researchers believe their findings could assist in the development of personalised medicine for people with this altered inflammatory response. New drugs that target inflammatory responses may prove to be effective for preventing adult heart disease and stroke.


Oral insulin trial

Researchers have begun a clinical study of oral insulin to prevent or delay type 1 diabetes in at-risk people.

Type 1 Diabetes TrialNet, a United States-based National Institutes of Health-funded network of researchers dedicated to the understanding, prevention, and early treatment of type 1 diabetes, is conducting the study in more than 100 medical centres across the United States, Canada, Europe, and Australia.

“Our goal is to prevent type 1 diabetes or to delay it as long as possible. If diabetes can be delayed, even for several years, those at risk will be spared the difficult challenges of controlling glucose and the development of complications for that much longer,” said TrialNet study chair Jay Skyler, MD, of the University of Miami.

In the study, researchers are testing whether an insulin capsule taken by mouth once a day can prevent or delay diabetes in a specific group of people at risk for type 1 diabetes. An earlier trial suggested that oral insulin might delay type 1 diabetes for about four years in some people with autoantibodies to insulin in their blood.

Animal studies have also suggested that insulin taken orally may prevent type 1 diabetes. Some scientists think that introducing insulin via the digestive tract induces tolerance, or a quieting of the immune system. Insulin taken orally has no side effects because the digestive system breaks it down quickly. To lower blood glucose, insulin must be injected or administered by an insulin pump.



Pacemaker for MRI

Medtronic have started an international clinical study to confirm the safety and efficacy of the Medtronic EnRhythm MRI SureScan pacing system, the first-ever pacemaker system to be developed and tested specifically for safe use in Magnetic Resonance Imaging (MRI) machines under specified scanning conditions.

Each year nearly one million pacemakers are implanted in patients worldwide. The company notes that while improvements to pacing technology have continued since its development nearly 50 years ago, this advance marks a concerted effort to pursue compatibility with MRI scans, an important healthcare diagnostic for many conditions.

“For important safety reasons, regulatory agencies worldwide prohibit individuals with implantable cardiac devices from receiving MRI scans,” said Steve Mahle, president of the Cardiac Rhythm Disease Management business at Medtronic. “Medtronic has thoroughly researched the risks to patients and designed a pacemaker and lead system from the ground up that we expect will help many, many patients take advantage of the benefits of MRI technology.”

The trial, a prospective, randomised controlled, unblinded, multi-centre study, is planned to occur at hospitals in Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Switzerland, United States, and United Kingdom; procedures are expected to begin outside Europe later in the year. Approximately 350 individuals will participate in the study, and eligibility is based on the clinical indication for pacemaker implantation and a willingness and ability to undergo elective MRI scanning. The expected study duration is approximately 24 months.


PLoS ONE launched

The electronic scientific journal PLoS ONE was launched late December last year. The journal publishes primary research from all areas of science and employs both pre- and post-publication peer review to maximise the impact of every report it publishes. PLoS ONE is published by the Public Library of Science (PLoS), the open access publisher whose goal is to make the world’s scientific and medical literature a public resource.

PLoS has taken a close look at the way scientific and medical publishing works now, and has asked how the Internet can be used to make it work better. As a result, virtually everything about PLoS ONE is new: the peer-review strategy, the production workflow, the author experience, the user interface, and the software that provides the publishing platform.

Harold Varmus, co-founder and chair of the Board of PLoS and president of the Memorial Sloan-Kettering Cancer Center, said: “For those of us who have been engaged with PLoS from its conception, the launch of PLoS ONE is tremendously exciting – this is the moment when we seize the full potential of the Internet to make communication of research findings an interactive and fully accessible process that gives greater value to what we do as scientists.”



World’s smallest baby

The world’s youngest gestational age baby, born at 21 weeks and six days, has been allowed to go home after surviving nearly four months in neonatal intensive care. Amillia Sonja Taylor was born on 24 October, 2006 at Baptist Children’s Hospital of Miami, United States. She weighed 284 grammes and measured 24 centimetres in length, slightly longer than a ballpoint pen.

Doctors describe her as a miracle baby and it is considered a new world record as no baby born before 23 weeks has previously survived according to the University of Iowa Health Care’s Department of Pediatrics, Division of Neonatology, which maintains a registry for the world’s tiniest babies.

Because Amillia was conceived by in vitro fertilisation, it was possible to pinpoint her exact gestational age. Amillia was delivered via C-section after attempts to delay a premature delivery failed. She was breathing without assistance at birth and even made several attempts to cry. American Association of Pediatrics indicates that babies born at less than 23 weeks of age and 400 grammes in weight are not considered viable.

William Smalling, MD, neonatologist, Baptist Children’s Hospital, said: “It may be that we need to reconsider our standard for viability in light of Amillia’s case. Over the years, the technology that we have available to save these premature babies has improved dramatically. Today, we can save babies that would have never survived 10 years ago.”


New leukaemia treatment

A group of Spanish scientists have recently discovered a new line of treatment for patients with acute lymphoblastic leukaemia. The study is published in Blood, the official journal of the American Haematology Association.

The discovery is applicable to a special group of patients with this disorder – those who show the cellular control pathway known as WNT as altered, and whose prognosis of this tumour disease is serious.

The discovery provides a rational basis for being able to use a series of drugs for this disease – such as quercetine (which produces a programmed death of acute lymphoblastic leucemia cells) or Decitabine, medication, already used with other kinds of pathologies. This group of medicines should help enhance chemotherapy results and raise the rates of survival amongst these patients. Clinical trials are ongoing.


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