Author: David Bradley

It’s not the most likely request you’ll hear at your local flame-grilled burger joint, but according to (KSU researchers, antioxidants in rosemary could help reduce the potentially harmful formation of heterocyclic amines during the “barbecuing” process. That’s all well and good, but who wants a burger tasting of rosemary, now if they could demonstrate the same benefits with onions, and a six-pack of beer, that would be a different matter.

According to the June issue of Scientific American, a growing number of dissenting researchers are accusing the US government and medical authorities – as well as the media – of misleading the public about the health consequences of rising body weights. These researchers suggest that excess body weight may not be the serious health risk it is claimed (by others) to be.

As with the anti-antismoking lobby, there are always going to be dissenters in any argument concerning health and safety, who can cite examples of overweight smokers living healthy lives into their 90s. Anyway, if the fat and smoke don’t kill you, the airbag just might. At least according to a statistical analysis that is yet to be reported widely in the mainstream media.

Apparently, the National Highway Traffic Safety Administration (NHTSA) has reported that airbags saved some 10000 lives as of January 2004. But, statistician Mary Meyer of the University of Georgia, has carried out an analysis of the data to demonstrate that airbags actually increase the risk of death (when other factors are controlled for).

“NHTSA recorded 238 deaths due to airbags between 1990 and 2002, according to information about these deaths on their Web site,” said Meyer. “They all occurred at very low speeds, with injuries that could not have been caused by anything else. But is it reasonable to conclude that airbags cause death only at very low speeds? It seems more likely that they also cause deaths at high speeds, but these are attributed to the crash.

“For any given crash at high speed, we can’t know what would have happened if there had been no airbag; however, statistical models allow us to look at patterns in the data, and compare risks in populations, in a variety of situations.” The study was published this week in Chance (2005, 18(2), pp 3-16).

The new analysis directly contradicts earlier studies about the effectiveness of airbags, which have been required for drivers and front-seat passengers in all cars since the 1998 model year in the United States.

While the value of airbags seems dubious in the new study, the value of seatbelts is not. The analysis found that proper use of a seatbelt reduces the odds of death by 67 percent for any given speed category and airbag availability. Airbags, however, cause no statistical difference in car-crash deaths, except for unseatbelted occupants at low speeds, where the odds of death are estimated to be more than four times higher with an airbag than without.

It has been known for some time that airbags pose special risks to children and small women. Auto manuals routinely say young children, especially those in car seats, should not be put in front seats where they might be injured or killed by an inflating airbag.

The reason earlier studies have found that airbags save lives is that they used only a special subset of the available data, said Meyer. The Fatality Analysis and Reporting System (FARS) is a high-quality compilation of information about every highway accident for which a death occurred. The Crashworthiness Data System (CDS) is another high-quality dataset, containing random samples of all accidents. The previous studies used FARS, and Meyer’s study used CDS.

“When we look at the random sample of all accidents, we find that airbags are associated with increased risk of death,” she said, “and this increase is due to more deaths with airbags in low-speed crashes and no seatbelts. However, if we limit the dataset to include only collisions in which a fatality occurred, we get a significantly reduced risk of death due to airbags.”

By way of analogy, Meyer explained it this way: “If you look at people who have some types of cancer, you will see that those who get radiation treatment have a better chance of surviving than those who don’t. However, radiation is inherently dangerous and could actually cause cancer. If you give everyone radiation treatment, whether they have cancer or not, you will probably find an increased risk of death in the general population.

“Making everyone have airbags and then verifying the effectiveness using only fatal crashes in FARS is like making everyone get radiation and then estimating the lives saved by looking only at people who have cancer. Overall, there will be more deaths if everyone is given radiation, but in the cancer subset, radiation will be effective.”

The new study directly contradicts assertions about airbag safety on the NHTSA Web site, said Meyer. The correct analysis is important to obtain now, because in only a few years, there will be virtually no cars on the road without airbags.

“We are confident that our analyses better reflect the actual effectiveness of airbags in the general population [than earlier studies],” said Meyer. “The evidence shows that airbags do more harm than good.”

A Sciencebase reader emailed to ask where they could find more information on Isolagen and its research into a system for eradicating wrinkles and facial scars. So here’s what we found:

Isolagen specializes in the development and commercialization of autologous cellular therapies for tissue regeneration and on May 23rd unveiled a design for an automated system to propagate and harvest cells more efficiently and cost effectively than other cell harvesting systems currently available. The ACE system could be used by cell and tissue companies worldwide and a successfully implemented ACE system would dramatically improve the time and cost of propagating and harvesting cells.

“We’ve invested significant resources to make the cell propagation process scalable, consistent and cost-efficient,” said Isolagen’s Chairman and interim CEO Frank DeLape. “The Automated Cellular Expansion (ACE) System is a simple solution that should enable us to introduce the Isolagen Process on a global scale, and will allow us to pursue licensing opportunities with organizations engaged in cell propagation and harvesting.”

Experts in the cell biology field acknowledge the potential significance of the ACE technology. “This system could significantly reduce the time and resources needed by any research or commercial lab that grows cells, while ensuring the consistency of cell growth and reducing the potential for culture contamination,” said Dr. Mark P. Lewis, Director of Research Operations and Senior Lecturer at Eastman Dental Institute of University College London.

Isolagen is best known for its patented Isolagen Process in which a patient’s own cells are used to correct and reduce the normal effects of aging and replenish deficiencies caused by the loss of fibroblast cells as a person ages. An aesthetic dermal application is currently available in the UK and is in Phase III pivotal clinical trials in the US. A Biologics License Application is expected to be filed with the FDA in late 2005. In addition to dermal indications, Isolagen is researching the use of autologous cellular therapies to treat gum recession, acne scarring and wound healing among other indications.

Growing Cells: Effective But Not Efficient

Cell propagation in Isolagen’s London and Houston laboratories is effective, but labor-intensive and time consuming. The Isolagen Process begins when a physician takes a small tissue sample from which millions of fibroblast cells are extracted and allowed to multiply in the laboratory. The regenerated fibroblast cells are then injected into the patient’s wrinkles when the cells reach a target quantity.

In preparing for its global market launch, Isolagen devoted significant resources to create a system that would make cell propagation and harvesting scalable and more efficient. Several years ago, a team of Isolagen scientists and engineers set out to design an automated cellular expansion (ACE) system that would substantially improve capacity and operating margins.

“The original business plan for Isolagen called for a single lab in every country, so the concept of scalability was not a priority,” said Mr. DeLape. “Our science has advanced to the point that we now envision a single laboratory serving multiple continents utilizing an efficient method of cell propagation and harvesting on a commercial scale.” Mr. DeLape noted the company recently announced the acquisition of a facility in Neuchatel, Switzerland intended to service Europe, Asia and Africa, and the purchase of a lab in Exton, PA to service the Central and South America and the United States once FDA approval is obtained.

ACE Advances Cell Propagation

The ACE unit consists of two separate and distinct parts. The first is a permanent unit, housing circuitry, pumps and a thermo-electric heater. The second part is the disposable unit, which contains a “cell tower,” media bags, cell separator and a sterile tubing for media flow. Cells are placed within the cell tower, which is designed to accommodate the growth of the cells, eliminating the time-consuming transfer of growing cells into new flasks. Every step, from feeding the cells to the harvesting of the injection syringes, will be executed in a sterile, closed-loop system.

The design eliminates nearly all human intervention, dramatically reducing the chance of contamination and the technical labor and monitoring associated with the process. And, the footprint of the Isolagen ACE unit as designed is small, allowing for modular stacking and maximum space efficiency.

“We are confident that we can maintain the quality and consistency of cell production, realize substantial savings and gain tremendous efficiencies through the use of the ACE System,” said Mr. DeLape. “Although ACE was developed to provide large-scale improvements in capacity and operating margins for the production of the Isolagen Process, we believe that ACE represents substantial improvements in cell propagation and harvesting for many other applications. Following the anticipated successful implementation of ACE for the Isolagen Process, we intend to seek licensing opportunities with other cell-based companies thereby creating a new revenue stream for our shareholders.”

The Isolagen ACE system was designed in collaboration with Fairway Medical Technologies and International Biophysics Corporation, leaders in medical device and equipment technology.

Logistical Advances Inherent with ACE

This fully automated, sterile closed-loop system is designed to offer enhanced benefits for other aspects of the Isolagen Process. The ACE design secures and records the identification of each patient’s cells through every step of the process — from biopsy to injection — creating a clear electronic chain of custody. Cells will be contained in a cell tower, which is designed to accommodate the expansion and growth of the cells and monitor cell growth and cell count to effectively predict when the target number of cells will be reached. In addition, Isolagen intends to utilize cryogenic preservation and freezing technology to allow maximum flexibility in scheduling treatments.

Next Steps

Isolagen intends to introduce ACE technology in the UK and its new Swiss facility during 2006.

About Isolagen

Isolagen specializes in the development and commercialization of autologous cellular therapies for soft and hard tissue regeneration. The company’s product candidates are based on its proprietary Isolagen Process and are directed toward dermatology — facial rejuvenation, gingival disease — gum disease, vocal cord lesions, and wound treatment. Based on the accumulated experience of the company through its pre-clinical studies, clinical trials and treatment of patients in the United Kingdom, the company believes that the Isolagen Process utilizing a patient’s own cells creates a safe and effective therapy for facial rejuvenation. Pre-clinical and clinical studies for future autologous therapies are ongoing. Autologous cellular therapy is the process whereby a patient’s own cells are extracted, allowed to multiply and then injected into the patient. Isogalen’s product candidates are designed to be minimally invasive and nonsurgical.

For additional information, please visit: http://www.isolagen.com .