Clinical Research

You've really got to hand it to all those 15-minute oil change places that dot the American landscape: they know how to pull motorists in.

With their brightly colored signs and endless promotions, it’s no wonder they succeed in getting our business. Whether you’re driving a brand new sports car or sedan with 200,000 miles on it, you’re welcome to drive up, get fresh oil and drive problem.

But when it comes to bone marrow transplants, the sobering fact is that the age of the vehicle —in this case, your body — does matter.
Synthetic Genomics announceda multi-year research and development agreement with Lung Biotechnology to develop humanized pig organs using synthetic genomic advances. The collaboration will focus upon developing organs for human patients in need of transplantation, with an initial focus on lung diseases. 

In the United States alone, about 400,000 people die annually from various forms of lung disease including cancer. 2,000 people are saved with a lung transplant and about the same number are added to the transplant wait list annually. 99% of deaths due to lung failure are unavoidable because of the shortage of transplantable human lungs.
The esophagus carries food and liquid from the mouth to the stomach. There are two main types of esophageal cancer: adenocarcinoma and squamous cell carcinoma. The most common form of the disease in the U.S. is adenocarcinoma and is most prevalent in Caucasian men between the ages of 50 and 70.

Adenocarcinoma, which is one of the fastest growing cancers in the country, has also been linked to obesity – perhaps related to chronic exposure to stomach acid. According to the National Cancer Institute, about 18,000 Americans were diagnosed with esophageal cancer in 2013.

Brittle bone disease is a congenital disorder that results in fragile bones that break easily.  

A new study in Nature Medicine showed that excessive activity of an important signaling protein in the matrix of the bone called transforming growth factor beta is associated with the cause of the disease. It suggests that there may be common mechanisms that cause the decreased quality and quantity of bone in these different forms. 

"There are many genetic causes of brittle bone disease in children and adults," said Dr. Brendan Lee, professor of molecular and human genetics at Baylor and a Howard Hughes Medical Institute investigator. "We have discovered many of them but clinicians still cannot easily distinguish the different forms. 

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.