Purdue University researcher Richard Borgens developed a fascination with nerve regeneration during childhood, when he watched the newts in his father's aquarium regrow legs bitten off by fish.
Today, he's developing nerve-regeneration methods that may prove instrumental in treating spinal-cord injuries.
Borgens directs Purdue's Center for Paralysis Research and is the founder of Andara Life Sciences Inc., a startup whose treatments are showing promise in clinical trials.
One of Borgens' therapies involves the patented oscillating field stimulator device, which stimulates and guides nerve regeneration. As part of a clinical trial, the OFS was implanted nearly three years ago in 10 patients who suffered paralysis within 21 days before starting the treatment. Older injuries are harder to treat because cells damaged by trauma secrete toxins that destroy surrounding soft tissue.
The OFS was surgically removed at 15 weeks, and patients were followed for one year and tested to evaluate their sensory recovery. Some patients who had no feeling below the level of their injury experienced normal sensation in certain areas. Others regained sensation and motor function in their lower extremities but not enough to stand unassisted.
The positive results of the clinical trial were featured in a cover story in the January issue of the Journal of Neurosurgery: Spine.
"For us, that's an important landmark," Borgens said. "That took a long time getting there."
For patients whose paralysis is long-term, Andara is employing a combination of the OFS device and a neurotrophic drug in an attempt to restore movement. The device and the drug, which assists in sprouting new nerve tissue, have been effective on guinea pigs and are now being studied on dogs suffering natural spinal-cord injuries.
Andara's plan is to take testing to humans, using the device and the drugs, in late 2006 or early 2007. If the trial is successful, the company could get Federal Drug Administration approval to begin selling products thereafter.
The aim of Andara's research is to increase the quality of life for recipients of spinal-cord injuries, not necessarily to get them walking again, Borgens said. Gaining enough movement to prevent bedsores, for instance, would be considered a major accomplishment.
"Mobility in the upper arms is the difference in having a job and not having a job," Borgens said. "Walking is pretty far down the list on the things that are important to quadriplegics and paraplegics."
The market for Andara's paralysis products could be large. There are roughly 250,000 people in the United States living with spinal-cord injuries, and about 11,000 more join the ranks each year. Moreover, some of the drugs in its pipeline extend beyond the realm of paralysis to include possible treatment for Alzheimer's and Parkinson's diseases.
Launched in January from Purdue-licensed technology, Andara will establish a permanent office in Intech Park on the northwest side by the end of the year. Mark Carney, an entrepreneur and health care executive, is leading the company as president and CEO.
Carney is in the process of raising second-stage funds from investors and hopes to be finished by the end of the year. Borgens' research has received both state and private support. The Mari Hulman George Foundation gave $6 million and the Indiana General Assembly has pledged $1 million annually. The amount from the Legislature is split between Purdue and Indiana University, because IU also is a shareholder in the enterprise.
Besides Borgens, the other founders from Purdue are Riyi Shi, associate professor of basic medical sciences; Stephen Byrn, dean of the Department of Industrial and Physical Pharmacy; and Dan Smith, a doctor working with Byrn. Dr. Scott Shapiro, a professor of neurological surgery at IU who removed tumors from bicyclist Lance Armstrong's brain, also is a founder.
Borgens received his doctorate degree from Purdue in 1976 and has been at the university for 24 years.
Richard Borgens' treatment methods show promise on dogs with spinal cord injuries.