Experimental Spinal Cord Procedure Tested At Phoenix Hospital

By Andrew Bernier
Published: Friday, November 14, 2014 - 8:46am
Updated: Friday, November 14, 2014 - 1:38pm
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(Photo courtesy of Barrow Neurological Institute)
Jordan Fallis in a physical therapy session.
(Photo courtesy of Barrow Neurological Institute)
Dr. Nicholas Theodore performs on a patient.
(Photo by Andrew Bernier - KJZZ)
The scaffold device, created by InVivo Therapeutics Holdings Corp.

A recent spinal cord injury has left a young Scottsdale man without the use of his legs. But an experimental device never before used was implanted into his spinal cord, and while the hope is for him to walk again, that isn’t the main goal of the experiment.

25-year-old Jordan Fallis was attempting a backflip on a homemade dirt bike course when he didn’t get enough air on the jump.   

“I landed on my face and kinda folded my body and it broke my T11 in my spine" Fallis said. "So it fractured that and bent my spinal cord.”

The spine is a series of bones called vertebrae that connect together, creating a hollow column in the center reaching from the base of the skull to the top of the hip bone. That column protects the spinal cord, which is like a braid of hair. Each string of hair represents a nerve where signals travel between the brain and different parts of the body. When that spinal cord is injured, it disrupts or stops travel of those signals.

“In that bend that’s where all the nerves in there got smashed and it created an air gap in there" Fallis said. "And that’s what the nerves and the signals from the brain can’t cross over that gap. Which is why, from the waist down, I can’t move anything and have no feeling.”   

But the location of the break made Fallis a prime candidate to be first to test an experimental device to bridge that gap. Doctor Nicholas Theodore of the Barrow Neurological Institute at St. Joseph's Hospital implanted a scaffold which looks like an enlarged grain of rice. To implant it though, it required him to do something he had never done before.

“Actually opening the spinal cord so cutting the spinal cord open," Theodore said. "Irrigating and removing some of the cells that were injured and then also placing this bio-scaffold device to provide the cells a chance to hang onto something as the spinal cord attempts to regenerate.”       

The material of the scaffold is made from a very complex sugar, making the chemical bonds slowly biodegrade in the body, hopefully allowing enough time for the regenerating cells to replicate. With a very porous inside, the scaffold is meant to encase the damaged cord like a bandage, allowing for cells to use the scaffold as a brace as they attach to one another.   

However, the hope of the experiment is not necessarily that the patient regain the ability to walk, but that it does not adversely affect the patient.

“This study is designed not to see whether it works to make Jordan walk again" said Theodore. "I would be incredibly happy if that happens. But this study by the FDA is really a safety study. So the first patient was approved really so that we could see whether or not doing this was safe.”   

Initially approved by the FDA, strict experimental regulations state that if a patient like Fallis were to be harmed in any way by the scaffold, the implant would have to go back to animal testing.

But initial tests on animals show a much more developed spinal cord than those without the scaffold. Combine that with an accelerated recovery so far for Fallis, he remains hopeful that one day he will be able to get back on the bike.

“If my legs come back I’m going to be right back on my dirt bike and doing the tricks and things I want,” Fallis said.

Fallis was discharged from the hospital Thursday and will soon begin his outpatient rehabilitation.

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