Maryland companies near regeneration of tissue, bone

Research quickens on how master cells repair damaged areas

Biotechnology

April 11, 1999|By Mark Guidera | Mark Guidera,SUN STAFF

During the next few months, doctors at three U.S. hospitals are expected to begin giving breast cancer patients who have undergone chemotherapy infusions of an experimental cell-based solution in the hope of restoring the vigor of the patients' bone marrow and immune systems.

The new drug, Stromagen, made by Baltimore-based Osiris Therapeutics Inc., is an outgrowth of research efforts to regenerate diseased and damaged body parts using "master" cells, known as stem cells, which give rise to other more specialized cells in the body.

A growing number of biologists and biotechnology executives believe that over the next five to 10 years an array of new stem cell-based therapies, already used to reinvigorate blood weakened by some cancer treatments, will become commercially available for treating a range of ailments, from torn knee cartilage to brain neurons ravaged by Parkinson's disease.

These master cells, which until just a few years ago were not well understood, are giving rise to an industry, with Maryland companies playing prominent roles.

"The age of regenerative medicine is really on the doorstep," said Daniel Marshak, Osiris' chief scientist.

Richard Garr, co-founder and chief executive officer of privately held NeuralSTEM Biopharmaceuticals Inc. in College Park, agrees. "I believe in the next five to 10 years we'll see stem cells used as a routine first-line therapy for connective and structural tissue problems, [blood] treatments, and Parkinson's," he said.

Stem cell treatments for Alzheimer's disease, stroke and other central nervous system, or CNS, disorders will "certainly" be in human trials, Garr predicts.

Implanting stem cells to regener- ate neurons in the brain may sound like science fiction.

But it's not as far-fetched as it may seem. Swedish scientists have already implanted primary fetal tissue in a small group of Parkinson's patients, and report that they appear to be doing remarkably well.

"They did before and after films and the difference is really amazing," said Garr, who has seen the footage.

Dr. John Gearhart, a genetics and stem cell expert at the Johns Hopkins University School of Medicine, agrees that the optimism is not unfounded. Research in the field is moving "very rapidly," said Gearhart.

Breakthroughs in the past year have made a once-obscure niche of scientific inquiry a topic of discussion in the boardrooms of pharmaceutical companies, say experts.

"Pharmaceutical companies no longer are regarding stem cell research as a marginal activity," said Christine Copple, NeuralSTEM's chief operating officer. "There is now this halo around stem cell technology. Drug companies clearly see the market potential."

By some company experts' reckoning, that market potential is vast for stem cell-based treatments, dubbed "liveware" by some in the industry.

James S. Burns, Osiris' chief executive officer, estimates the potential for bone, cartilage and other connective-structural stem cell treatments to be $15 billion worldwide.

NeuralSTEM's Copple believes that effective stem cell-based treatments for neuro-degenerative diseases, such as Parkinson's, are also multibillion-dollar markets.

For now, the only stem cell treatment on the market is a blood-filtering device marketed by Baxter International Inc. to treat cancer-related transplant patients. Analysts estimate that it could yield $200 million annually. The device is based on work by Hopkins oncologist Curt Civin, who came up with the idea of filtering out healthy stem cells for reinfusion.

Future commercially available stem cell treatments should yield "rather significant" medical benefits too, predicts Gearhart, though experts caution that a number of hurdles remain.

The emerging industry got a jump-start in November with announcements by Gearhart and his Hopkins team and another team at the University of Wisconsin that they had been able to isolate and grow in the laboratory stem cells taken from human embryos.

The breakthrough was considered significant because such stem cells are thought to have the ability to divide without limit and give rise to virtually any type of human cell.

That might have huge implications for growing replacement tissues for organ transplantation, controlling diabetes, and a host of other conditions, say experts.

Then just this month, Osiris scientists disclosed in Science magazine that they had been able to isolate and grow stem cells from bone marrow samples taken from adult donors and then manipulate those cells to grow or "differentiate" into three specific types of cells: bone, cartilage and fat. Marshak said Osiris believes that it can replicate the success with muscle, tendon and other structural and connective tissues.

The company, he said, hopes to be able to seek Food and Drug Administration approval soon for human tests that will attempt to regenerate bone and cartilage damaged by orthopedic injuries and osteoarthritis.

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