Peoria resident first to receive experimental spinal surgery

Publication Source: Peoria Times

May 27, 2015
By Darrell Jackson

What would you do if you had the chance to be involved in a medical experiment after a vicious accident that left you paralyzed from your stomach down?

For Peoria’s Jordan Fallis, there was no second guess or hesitation about being the first in the country to have an InVivo Therapeutics Neuro-Spinal Scaffold device implanted into his spine.

Fallis, who has lived in Peoria for the past four years, grew up in Arizona and has been riding motorcycles since he could walk.

“Yeah, I am kind of a daredevil and loved doing stuff on my BMX bike and completing tricks,” Fallis said. “I had been riding for years when I decided to try a flip that I had done on my BMX bike.

While riding in northern Peoria Oct. 13, 2014, Fallis hit a jump and tried to do a back flip on the motorcycle but didn’t get the motorcycle all the way around.

“I was riding my motorcycle and tried to do a back flip on my dirt bike,” Fallis said while sitting at his apartment in Peoria. “It was the first time I had tried it on my motorcycle, I had done it numerous times on my BMX bike, and I just under-rotated the flip.”

Fallis said he knew he was going to be short on the flip and tried to bail out, when he landed face first, compressing his spine.

“We were so far off the road that the ambulance could not get to me,” Fallis said. “Luckily, my buddies got their truck and some plywood and strapped me to it and drove me to the road where the ambulance met us.”

When they arrived, the EMTs said they couldn’t do anything for him and called for a helicopter, which would fly him to St. Joseph’s Hospital in Phoenix.

“When I got to the hospital, they did the usual MRI, X-rays and showed me what had happened to my spine,” Fallis said. “They told me right away that InVivo had made this scaffold and they had had success in animals, but they had never done it in humans. They had been approved and said they were looking for someone like me and my injury and I said,  ‘I am in.’”

When Fallis arrived at St. Joseph’s and was told of the trial program, he quickly agreed and Dr. Nicholas Theodore was contacted to inform him the hospital had a subject willing to be part of the program.

InVivo Therapeutics initiated a pilot study with the Neuro-Spinal Scaffold device for acute spinal cord injuries (SCI) patients and has now treated the first patient (Fallis). InVivo has strong data using the device alone or in conjunction with seeded neural stem cells in rats, pigs, and monkeys.

“The way I was told, the surgeon (Dr. Theodore) was approved to do the surgery and I was really the right injury at the right time,” Fallis said. “I had the accident in the late afternoon and the surgery was done around midnight.”

Theodore said the scaffold acts like a bandage that is implanted inside the spinal cord and Fallis’ surgery was part of an FDA approved study.

“This study was done for safety and is an FDA pilot study and mainly is being done to see if it is safe to open the actual spinal cord,” Theodore said by phone.

Theodore described the Neuro-Spinal Scaffold as a small (smaller than a quarter) foam-like piece that was surgically implanted at the epicenter of the wound. He described it acting like a trellis, which allows the cells to grab onto the scaffold like a plant to a trellis.

“Within minutes of getting to the hospital after getting the call about (Fallis), we had surgery ready to go,” Theodore said. “The MRI showed a compression fracture and when we got started I was a little nervous because I had never opened the sac around the spinal cord before. When we got it opened, I was expecting a tear in the cord, but it was intact and we implanted the scaffold.”

Theodore said most patients with this type of injury do not get better, but they have already seen amazing improvement in the eight months since Fallis’ accident. He has gained feeling down to his thighs, can move himself onto the bed while using his hips, and has more feeling where he did not have feeling before.

“I couldn’t feel anything below my mid-chest after the accident,” Fallis said. “Now, I can feel the top of my thighs, can move my hips and now I can move in and out of my chair on my own almost with ease.”

While the surgery is showing amazing results, Theodore said it is too early to start calling this the cure to paralysis.

“What this does is it sets up an environment to preserve the cells that are at risk after the injury,” Theodore said. “Nobody knows any answers for what healing may occur, but if it is successful, we can combine it with stem cell research and may eventually find a cure for paralysis.”

The NeuroScaffold Foundation came about through a series of coincidences after Yara Goldstein and her husband met the former CEO of InVivo Therapeutics more than five years before human clinical trials began on the scaffold.

Both Goldsteins were so intrigued by the biopolymer device that they decided to buy stock in InVivo Therapeutic in 2010, when the company went public.

After the second subject had the scaffold implanted, Yara Goldstein reached out to the second subject and a friendship began. That friendship led to advocacy and fundraising.

From that action, the NeuroScaffold Foundation was born and Yara Goldstein became the executive director of the organization that aims to raise awareness and funds for future patients who will receive the Neuro-Spinal Scaffold procedure.

“The directors of the NeuroScaffold Foundation strongly believe that the Neuro-Spinal Scaffold (NSS) has allowed patients to regain function below their level of injury and will give them the opportunity to walk again,” Goldstein said. “We feel it is imperative they receive physical therapy multiple times a week as well as specific medical equipment to allow their muscles to remain healthy and intact while the NSS does its job.f

“The Foundation’s goal is to provide necessary medical equipment and assist with physical therapy costs for NSS recipients, where there is a gap in health insurance coverage,” Goldstein said. “We really appreciate all the support and donations we have received to date, which has allowed us to assist patients one and two.  Our next step is preparing for the next three patients and beyond.”

The foundation is a non-profit assisting those with spinal cord injuries who are recipients of the Neuro-Spinal Scaffold. Prior to establishing the foundation, Goldstein set up a GoFund me account to anyone who wishes to help Fallis with his recovery and you can go to http://www.gofundme.com/Jordan-Fallis-PT to donate.

They will also be supporting the Jammin for Jordan benefit concert and dinner 3 to 9 p.m. May 31 at Lakeside Bar & Grill, 9980 W. Happy Valley Pkwy, in Peoria.

Fallis said all this assistance from people has been overwhelming and he said he can never thank people for what they have already done.

“I know I did this to myself, but I also believe that things happen for a reason,” Fallis said. “I plan to take my first steps on the one year anniversary of my accident (Oct. 13, 2015) and hopefully that will be the best thank you I could give.”

Editor’s note: There is no affiliation between the NeuroScaffold Foundation discussed in the story and InVivo Therapeutics or their current employees.

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