Human Trial For Spinal Injury Treatment Launched By Purdue, Indiana University

In a news conference at the Indianapolis Motor Speedway Trackside Media Center, the universities announced that the FDA-approved trial at IU is based on treatments developed at Purdue. Dogs suffering paralysis from natural causes regained partial function with the treatment.

In support of the effort, Mari Hulman George, chairman of the Indianapolis Motor Speedway, is contributing $2.7 million to Purdue and IU. The gift is being used to establish endowed professorships at both universities: a named professorship in the Purdue School of Veterinary Medicine's Institute for Applied Neurology and a named chair in the IU School of Medicine's Division of Neurosurgery.

"I am pleased to be able to help both Indiana and Purdue universities in their research to help victims of spinal cord injuries," said George. "In this season of Thanksgiving, perhaps this gift will help give more hope to those victims and their families who are looking forward to new developments. Our family has been touched by this, as have many. I very much appreciate what the state of Indiana is doing to help, and especially the efforts of Dr. Borgens and Dr. Nelson."

George's gift will augment funding from the state, which committed $1 million annually for two years to Indiana and Purdue universities to support the application of research on spinal cord and head injuries.

The human clinical trial will test whether weak electrical fields applied to spinal cord injuries can promote better functional recovery through regeneration of injured spinal cord nerve fibers. The electrical fields are imposed over the spinal cord injury through use of a new implantable medical device, called an extraspinal oscillating field stimulator.

The trial will begin later this year and is open to patients between the ages of 18 and 65 who have suffered a spinal cord injury. Patients must be entered into the trial within 18 days from the time of their injury; there are other exclusionary criteria that are available from the clinical trials coordinator.

Purdue Professor Richard Borgens, director of the Institute for Applied Neurology, said the state support coupled with George's contribution is helping speed the process of bringing promising experimental treatments into actual human clinical trials.

"In the past we have had to apply for grants and corporate sponsorships in order to fund human trials, and that process can take many years," he said. "Now we have been able, and will continue, to move more quickly into human trials with techniques found to be both safe and effective on animal patients."

Dr. Paul Nelson, Betsey Barton Professor and chairman of the neurosurgery division at IU, said the pairing of the two universities is unique. "This is the beginning of our research into treatments that can be used collectively to improve the regeneration of the injured human spinal cord," he said. "The IU-Purdue collaboration in spinal cord research is an important partnership. It fits the universities' drive to engage in translational research, which creates an effective bridge between basic science research and patient care."

Spinal cord injuries represent a growing medical and financial dilemma for state governments, yet only a few other states – Kentucky, Florida and Virginia among them – fund paralysis research.

The Indiana General Assembly approved the effort in spring 1999 and made the money available July 1999. The funds provide a stable operating budget for equipment and professional staff to conduct coordinated research and test new developments.