BresaGen moves slowly to grow stem cell work
Julie Bryant Staff Writer
The door leading to the headquarters of BresaGen Inc. opens with a quiet shoosh. Inside, a simple paper sign asks visitors to wait for the receptionist before stepping further into the Athens-based company's unassuming home office.

There is little indication that mere feet away lies a controversial stockpile of tiny human cells, plucked from human embryos, that could hold the key to new treatments for a host of fatal diseases and disabling conditions, including Parkinson's, diabetes and spinal cord injuries.

And while a raging Capitol Hill ethics debate over the collection, study and funding of those cells would lead observers to believe that there is wild demand for unfettered access to them, most of BresaGen's stash still lies undisturbed on a refrigerated shelf.

There are no scientists dashing down corridors, no order filling and no Fed-Ex trucks barreling down the driveway to BresaGen's front door.

In fact, there has been little more than a neatly controlled fuss over the company's stem cells.

"We've had inquiries from about 80 different organizations, but only filled a few orders," said BresaGen CEO John Smeaton, who, last year, brought the company's stem cell division to Athens from Australia, where BresaGen has its original headquarters.

Even nationally there has been slow-to-burn interest in the federally funded stem cell collections now held by 14 different entities across the globe, including BresaGen's.

The tame, but mounting, demand comes despite the fact that scientists regard stem cells as the building blocks of all human life, the "big bang" material that gives rise to a human being - and the foundation for a paradigm shift in medicine.

Stem cells, by definition, are blank-slate cells that can turn into just about any type of cell found in the body, such as a liver cell, brain cell, skin cell, even a blood cell. In theory, scientists could use stem cells to replace or restore damaged cells in the body - a theory that has left even the most seasoned researcher all a-quiver.

So why the controversy over stem cells? And why the limit on federal funding?

Stem cells are an especially touchy subject for the government because they are derived from human embryos - embryos that had to be destroyed before the cells could be extracted.

In funding stem cell research, the government is headed down the proverbial slippery slope, said Douglas Johnson, federal legislative director for the National Right to Life Committee, in a recent interview.

Typically, but not in all cases, the embryos are collected from fertility clinics, which discard embryos deemed unsuitable for implantation. The stem cells are extracted from the discarded embryos. Each embryo's stem cells give rise to a stem cell line.

Very simply put, scientists peer through microscopes at a tiny days-old mass of cells that forms the embryo and see, well, cells. Religious groups, on the other hand, say they see a miniature human being deserving of federal protection.

Recently the Bush administration revised its stance on the safety of research volunteers, stating that embryos used in experiments are to be regarded as human subjects whose welfare should be considered along with that of fetuses - which are more developed than embryos - children and adults.

To maneuver around the stem cell controversy, President George W. Bush set down a strict set of criteria for stem cell funding. Federal funds are used only for embryonic stem cell lines that existed prior to Aug. 9, 2001.

The stem cells also had to be derived from embryos created for reproductive purposes and were no longer needed for those purposes. Informed consent must have been obtained for the donation of the embryos and there must have been no financial inducements given for the donation of the embryo.

Those strict requirements have stirred the ire of the researchers, who say the Bush criteria will significantly hinder the medical advances that can be made using stem cells.

And what advances they say can be made: The theory behind stem cell research has raised hopes that scientists might one day be able to restore a stroke victim's ability to function normally - or even grow teeth in a petri dish and help the paralyzed walk.

Meantime, political debate has stymied an all-out land run on stem cells and, for now, the science is only trudging along.

Slow interest aside, it has been an exhilarating year for BresaGen, which found itself rapidly shedding its modest, university-based biotech-startup image as the company was pushed onto a global stage, taking its place alongside a highly select group of peers.

A select group
Shortly after Bush announced his decision to allow a limited sum of federal dollars to be used to fund some stem cell research, nearly a dozen entities, including BresaGen, were quickly identified as having eligible cell lines. Three more entities would join the group later.

"Bush made his announcement and all hell broke loose," Smeaton said. Reporters suddenly descended. There was even a CNN truck parked just outside, Smeaton recalls.

All the fanfare came after BresaGen was caught quite by surprise by a call from the National Institutes of Health (NIH), the research arm of the U.S. Department of Health and Human Services, just one month earlier, Smeaton said.

That call later developed into confirmation that BresaGen would claim a spot beside the other companies, universities and laboratories identified as having a combined total of 64 eligible stem cell lines. That number is now up to 78.

Abruptly, BresaGen became part of the centerpiece for a monster of a national debate.

Then 9/11 happened and, just as abruptly, the reporters scattered and the corridors were quiet again, Smeaton said.

Now, a little more than a year later, the trickle of orders at BresaGen is somewhat surprising. The company is, after all, one of the only 14 entities worldwide with eligible stem cell lines. BresaGen also is one of an even smaller number of the funded entities actually able to widely distribute its stem cells.

As of September, only three of the 14 entities listed on the NIH registry were actually distributing cells to researchers, said Della M. Hann, an NIH senior policy adviser in the Office of the Deputy Director for Extramural Research. BresaGen joined those three in October.

And of the 78 approved cell lines, only about a half-dozen are being used.

Smeaton, however, is less than shocked. Stem cell orders have reportedly been coming in at a fairly steady clip at some of the other funded labs that began distributing cells earlier than BresaGen, including at Australia-based ES Cell International and WiCell Research Institute, a subsidiary of the Wisconsin Alumni Research Foundation, which holds a patent on stem cells.

And many labs are simply not yet ready to receive stem cells, which can be tricky to grow, Smeaton said.

Add to that the controversy. Folks from both sides of the ethical debate have continually raised the subject of using adult stem cells, which, many say, can accomplish what embryonic stem cells can, minus the wrangling. Scientists disagree.

There are even questions as to whether the stem cell lines being funded now will ever give rise to products that could pass U.S. Food and Drug Administration (FDA) standards, according to researchers.

The existing stem cell lines were grown using mouse feeder cells, a common lab technique that allows human cells to grow on top of mouse cells, which aid, or feed, cell growth - but it is a technique that has rendered the current cell stash essentially contaminated, said BresaGen's Smeaton.

To top it off, scientists really aren't sure if stem cell research actually will lead to blockbuster cures and disease treatments. Troubling doubts have dimmed prospects for a flood of private-sector funding, making researchers that much more dependent on the rather gun-shy government officials who control federal purse strings.

And there surely will be patent squabbles over any future products made using stem cells.

There is more hype in stem cell research than in anything outside professional wrestling, said Richard Garr, CEO of a Maryland-based stem cell company, NeuralStem Inc.

"What we have is the wheel," said Arlene Y. Chiu, a program director at the National Institute of Neurological Disorders and Stroke, referring to stem cells. "It's a starting point."

Scientists must still develop the rubber and the gears to get to the car.

But BresaGen has faced these challenges calmly.

To date, BresaGen has secured $1.6 million in federal stem cell grant money, signed a tangle of required licensing and distribution agreements with the National Institutes of Health and made little vials of its prized stem cells available to other researchers for $5,000 a pop - a price recommended by the NIH.

Trying to cure Parkinson's
One of those vials recently made its way to the lab of one of the country's most preeminent stem cell researchers, Ronald D.G. McKay, chief of the molecular biology lab at the National Institutes of Health's National Institute of Neurological Disorders and Stroke, according to Smeaton.

There McKay is experimenting on neural stem cells in hopes that one type of cell in particular might give rise to a new treatment for Parkinson's.

"Embryonic stem cells quite clearly give rise to [dopamine-producing] neurons," said McKay, speaking recently before a group of journalists assembled at the NIH as part of a Knight Center for Specialized Journalism fellowship program on stem cells.

It is those dopamine-producing cells that conk out in the brains of Parkinson's patients, scientists believe. If new cells could be transplanted into the region where those cells have died, symptoms of the disease could be alleviated. Indeed, stem cell studies in mice afflicted with Parkinson's have shown promising results, McKay said.

BresaGen, which also collects revenue from other lines of work done mostly in Australia, including animal growth hormone production, is working on a similar treatment for Parkinson's and also is looking to tackle spinal cord injuries using stem cells therapeutically.

But so many things must happen before even human testing of such therapies can occur. So far only animal tests have been performed - albeit with some promising results. And there are so many questions about stem cells that are still unanswered.

"Our ignorance in this field is monumental," said Dr. Marvin C. Gershengorn, a scientific research director at the National Institute of Diabetes and Digestive and Kidney Disease.

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