Clinical Research

New research looking at the success of clinical trials of stem cell therapy shows that, when trials appear to be more successful, more discrepancies in trial data are also evident.

Discrepancies were defined as two (or more) reported facts that could not both be accurate because they were logically or mathematically incompatible. For example, one trial reported that it involved 70 patients, who were divided into two groups of 35 and 80.

The researchers found eight trials that each contained over 20 discrepancies.

The meta-analysis of 49 randomized controlled trials of bone marrow stem cell therapy for heart disease in the British Medical Journal identified and listed over 600 discrepancies within the trial reports. 

Preliminary results of a randomized, double blind, placebo controlled trial on osteoarthritis of the knee using ActiPatch Therapy have been announced.

BioElectronics Corporation says the initial interim analysis showed statistically significant results for the primary and secondary outcomes measures. The study is being led by Doctor Gianluca Bagnato, Division of Rheumatology, University Hospital Gaetano Martino, Messina, Italy. The final analysis of the full study data set will be carried out soon and the results have been accepted in the Annals of the Rheumatic Diseases and presented at the European League against Rheumatism 2014 conference.
XBiotech, a company involved in commercializing biological therapies, has published the results from its Phase I/II oncology study conducted at MD Anderson Cancer Center in Houston.

The study describes the outcome in 52 advanced cancer patients treated with their Xilonix™ non-cytotoxic, anti-tumor therapy. The so-called true human antibody therapy was reported to have an excellent safety profile and the report describes comprehensive measures of patient performance during therapy with Xilonix.

In 1993, five people died in a clinical trial of fialuridine, a nucleoside analogue to treat hepatitis B virus infection.

An analysis by the US National Academy of Sciences of all preclinical fialuridine toxicity tests, which included studies in mice, rats, dogs, and monkeys, concluded that the available animal data provided no indication that the drug would cause liver failure in humans. So it's been a 21 year search to try and find ways to make trials safer.

A report in The Lancet describes the first instance of human recipients receiving laboratory-grown vaginal organs. The research team describes long-term success in four teenage girls who received the vaginal organs, engineered with their own cells.

The first ever successful nose reconstruction surgery using cartilage grown in the laboratory has been done by the University of Basel. The details are upcoming in The Lancet.

The cartilage cells were extracted from the patient's nasal septum, multiplied and expanded onto a collagen membrane and then the engineered cartilage was then shaped according to the defect and implanted. The cartilage was grown from the patient's own adult stem cells and the technique was used with five patients, aged 76 to 88 years, with severe defects on their nose after skin cancer surgery.

A breakthrough could speed recovery and limit disfigurement for patients who have suffered large soft tissue trauma, as occurs with serious injury or cancer surgery.  

By biomedically engineering a muscle flap that includes a patient's own blood vessels, the team created tissue that could be transferred to other parts of the body along with the patient's blood supply. Current techniques – including grafts and synthetic material – for reconstructing such trauma often fail because of lost blood supply.  The scientists fabricated the flap using a variety of added cells and connective tissues to strengthen it. They tested it by reconstructing deep abdominal wall tissue defects in mice.

Body odor can convey a lot of personal information, according to new research from the Monell Chemical Senses Center and the U.S. Department of Agriculture (USDA) which reveals that immunization can trigger a distinct change in body odor. This is the first demonstration of a bodily odor change due to immune activation. 

In the study, 'biosensor' mice were trained to discriminate between urine odors from mice vaccinated against either the rabies virus (RV) or the West Nile virus (WNV). All training and testing trials were conducted using a Y-maze with odors randomly assigned to each arm of the "Y."

It's hard to find an article on food or metabolism that doesn't imply it has implications for predicting cardiovascular disease (CVD) or diabetes.
Because higher glucose levels have been associated with higher CVD incidence, it has been proposed that information on blood sugar control might improve doctors' ability to predict who will develop CVD, according to background information in the article.

But an analysis of nearly 300,000 adults without a known history of diabetes or cardiovascular disease showed adding information about glycated hemoglobin (HbA1c), a measure of longer-term blood sugar control, to conventional CVD risk factors like smoking and cholesterol didn't do much to predict CVD risk.

Researchers have noticed a link between Vitamin D and ASD for years. A new study explains how a lack of the vitamin could lead to problems in fetal and neonatal brain development, creating the symptoms of autism spectrum disorder.
Rhonda Patrick and Bruce Ames of Children's Hospital Oakland Research Institute showed that vitamin D is essential for the synthesis of serotonin in the brain. They also show that it may be important for the making the precursor to oxytocin, as well as for the formation of the oxytocin receptor and vasopressin receptors. All three of these chemicals, which are both neurotransmitters and hormones that regulate body functions, are crucial for social behavior.