How a tiny fiber implant is giving new hope to people with spinal cord injuries – AZCentral.com

The Neuro-Spinal Scaffold was designed to be a three-dimensional bandage. Wochit

Nick Stockwell attempts to hold himself upright as part of his daily physical therapy sessions.(Photo: Alden Woods)

TUCSON One after another, everythingcracked.

First wentthe brick wall he never saw and the front end of the Chrysler minivan he never meant to send crashing into it. Then the impactshatteredhis ankles, the screen of his cellphone and his right arm, and finally, agonizingly, the fragile vertebrae that surrounded Nick Stockwells spinal cord.

Paramedics came to the Holiday Inn parking lot and pried him out of the front seat. He tried to stand, but only half of his body responded:In his chest and arms he felt nothing but pain, and in his legs he felt nothing at all. He collapsed to the pavement.

They gave Nick five shots of painkillers, loaded him into an ambulance and made the nine-mile drive to Banner University Medical Center in Tucson. After hours of X-rays and MRIs, Nick borrowed his uncles phone and called his dad in Michigan, where it was 4 a.m.

Something really bad happened, Nickstarted,and then hetold his dad everything he could remember: He had pulled up to the hotel and unhooked his seatbelt, already reaching for the pizzashe was about to deliver.Inside the hotel was a big tip, he was sure of it. Ten dollars, maybe. Then his body convulsed and his foot jammed into the gas pedal, and at the hospital a doctor showed him an MRI and pointed to where his T12 and L1 vertebrae had shattered.

And now hewas paralyzed.

As his parents bought the first plane tickets to Arizona, a research coordinator from the University of Arizonacame to Nicks room. He would need metal rods and screws to hold his spinal cord in place. Had his injury happened some other time, near some other hospital, that would have been all they could do.

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But spinal cord research was finally advancing.The hospital was looking for patients to enter in the INSPIRE study, the most promising nationwide clinical trial amonga handful attempting to cure paralysis.

After the surgeon stabilized his spine, the researcher explained, he could implant a tiny device designed to prevent scarring and guide nerves as they regenerated. To do that, the surgeon would have to do something radically new: intentionally cut intoNick'sspinal cord.

Eleven people across the country had been given the Neuro-Spinal Scaffold. Did he want to be the twelfth? He had little time to decide.The scaffoldhad to be inserted within 96 hours of his accident.

He tried to focus, to turn the pain off. So much had happened. So much had changed. Now the researcher was handing him a thick packet of information and consent forms.At the present time,Nick read,there is no evidence that the Scaffold will provide any benefit to you.

The pain and morphine blurred all Nicks thoughts. Everything was happening so fast.

Im not sure, he told her.

Nick had moved to Tucson two months earlier,with a degree in human biologyand hopes of a better job than he could find back home in Michigan. He moved in with an uncle and spent his time playing video games and hiking up Mount Lemmon. Papa Johns was the first place to offer him a job, so hedelivered pizzas in an07 Chrysler minivan while he tried to figure out how to start a career at 27 years old.

Then he made a delivery to the Holiday Inn by the airportand became one of 17,000 Americans whosustainspinal cord injurieseach year.

The human spinal cord is remarkably fragile. Soft and spongy, it's bright pink like a blob of bubble gum thats been stretched into an 18-inch tube.Its only protection is the ladder of vertebrae that surrounds it. When those bones break, they can press against the cord or slash into it. Some trauma happens quickly enough to cut the cord entirely.

In the days after Nicks injury, the area around his spinal cord was a mayhem of inflammation, dead tissue and shards of bone. The cord was bruised and swollen, but the mess made it impossible for his doctors to know if it had been severed.

His body was limp below the small of his back. He couldnt feel when his dad ran a sheet of paper across his toes. His calves were frozen. Any muscle movement fizzled in his thighs, dissolving into a wave of tingles just above his knees. Using the American Spinal Injury Association Impairment Scale, Nicks doctors diagnosed it as an AIS A injury. He had no feeling or movement below the crushed vertebrae.

About 15 percent of patients with AIS Ainjuries have at least some sensation come back.If he was going to recover naturally, Nicks doctor told him, the sensation would come back to his legs within 24 hours. For almost three days Nick waited, downloading games onto an iPhone he borrowed from his dad and watching superhero movie reruns. Nothing.

And for nearly all of human history, that has been the only treatment for spinal cord injuries: Nothing. A 5,000-year-old document written by an Egyptian physician, believed to be a man named Imhotep, called paralysis an ailment not to be treated. The Greek scholar Hippocrates wrote that physicians who tried to cure spine injuries are all stupid. The Romans believed paralysis was a sure sign of impending death.

Now there were stem cells and spinal fusions, and still nothing could cure human paralysis.

Theres never been a successful treatment, said Frank Reynolds, co-inventor ofthe Neuro-Spinal Scaffold. Not one.

Reynolds, a self-promotingson of Irish immigrants, was paralyzed in 1992, when surgical screws damaged his spinal cord. He testified at an FDA hearing, and the screws were pulled off the market. Then he focused on walking again. That took just seven years, and so he moved on to finding a cure for paralysis.

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We were completely abandoned, he said, and he enrolled in a masters program in drug discovery at the University of Pennsylvania, bringing with him mental sketchesofa spinal scaffold.

Then he met Robert Langer.

An MIT professor with more than 400 patents issued in his name, Langer had engineered a way to create artificial organs and skin. In the 1990s, one of his graduate students asked about building spinal cords. It was supposed to be impossible.

Im used to that, Langer saidyears later.

By 2002 he was curing paralyzed rats.

They met at a fellowship program in 2005. Reynolds told Langer he wanted to build tiny devices to help spinal cord patients. Langer said he was already working on those, and later that year the two inventorsfounded InVivo Therapeutics. The company offered only one product.

Theres never been a successful (spinal cord injury) treatment. Not one.

The Neuro-Spinal Scaffold was designed to be a three-dimensional bandage. A small tube just over a centimeter long, the scaffold requires a surgeon to slice open the dura mater, a leathery membrane with aLatinname that translates to "tough mother." The scaffold is then placed inside the spinal cord, where InVivo believedthe device can prevent scarring and direct the bodys natural regrowth of tissue and nerves.

After six weeks, its work done, the scaffold dissolves in the body.

When Nick Stockwell arrived at Banner University Medical Center in Tucson, 11 AIS Apatients had received neuro-spinal scaffolds. Five had improved to AIS B,regaining some sensation but no movement.The first patient, Jordan Fallis, was living on his own at AIS C.Two had died, but those were unrelated to the scaffold, the researcher assured him. Trials on monkeys had made most of them walk again.

While were in there, the researcher said.We can do this.

The time to decide grew short. Nick told her he wasnt sure. He wanted to ask his mother, a surgical nurse.

What do you think about it? Nick asked when his mother arrived.

She had never heard of the trial. But it was worth a chance.I dont know why you wouldnt," she said.

Sixty-seven hours after his vertebrae cracked, Nick signed the consent forms. The signature was scratchy and off-line. He had to use his weaker left hand, because hisright arm had been broken in the crash.

A team of nurses and surgeons placed Nick face down on the operating table. The anesthesia kicked in, and Dr. Travis Dumont opened the skin of Nicks back. Inside was a jumble of bone and dead tissue. Over the next five hours, Dumont rearranged the bundles of nerves and bone, locking them in place with a pair of steel rods and a handful of screws.

A surgical assistant brought over a microscope. Dumont nicked open the back of Nicks spinal cord and washed out the tissue that had liquefied after the injury. With a thin pair of tweezers, he picked up the tiny scaffold and placed it inside the cord.

It slid in easily.

Three weeks passed. Nick lived in bed now at a rehab center in Tucson. The rooms only window looked out at a sidewalk and the parking garage. On a table beside his bed were two phones he used to play Final Fantasy V and a remote for the TV that was always on. He changed his Facebook picture to one of Bran Stark, a paralyzed character in "Game of Thrones."His parents flew back to Michigan, and few people visited.On a whiteboard in front of his bed was his daily physical therapy schedule and a note from the nurse: Patient goals: Be able to transfer and take care of himself on his own.

Nick thought the sensation was spreading farther down his legs, but so far the surest sign of progress was that he could sit upright and hold himself there. That was also the most painful part of his day.

How are you doing? his doctor asked,walking in now for his daily rounds. Doing good? Sleeping good?

Ten hours a night, Nick said, because his only other choices were to stare at his phone or watch the TV movies that played on repeat.

Ten hours a night is not good, the doctor said,shaking his head. Nick was sleeping too much and not moving enough.You need to do more therapy.

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Nick grimaced and said nothing. He hated physical therapy, his daily routine of trying to will his body to do what it no longer could: sit up, lean forward, straighten his legs. Each hour in the gym was pain, failure and the overwhelming sense that this was his life now. He stretched for a stress ball three feet in front of him, and could never reach far enough to grab it.

Dr. Dumont came for a follow-up appointment and said little. The scar in Nicks back had just begun to heal, and already the scaffold was starting to dissolve.

It had finally started to set in, how his life was irreparably changed. He needed to move back to Michigan, where his family could help take care of him. In just a few weeks his goals had shifted,from finding a career in Tucson, to wiggling his toes, to being able to shower on his own.

Dont you want to walk? his parents asked when they were still in town.

Yes, but thats unrealistic, he told them. I dont want to disappoint myself.

The doctor left and a nurse helped Nick pull on a pair of red gym shorts. Half an hour later, a physical therapist named Jenny walked in. She brought a thick wooden board, a frictionless blanket and a sinewy assistant. Together they lifted Nick off the bed, placed the blanket under his hipsand slid him across the board. Nick crumpledinto a waiting wheelchair.

You ready? Jenny asked.

Lets do this, Nick said, and they rolled him toward the gym.

Jordan Fallis 28, talks about a motorcycle he is working on and hopes to ride. Fallis injured his spine doing a motorcycle trick.(Photo: Tom Tingle/The Republic)

Jordan Fallis knew right away. The dirt bike still hummed beside him inthe Arizona desert. It was supposed to be a backflip, a routine trick in a routine visit to his homemade ramp,but he couldnt rotate the bike all the way. His head hit the ground first. His legs tingled. Then, nothing.

I was 90 percent sure that I broke my back, Jordan said two years later. I was pretty positive of that.

His riding spot was remote, away from the reach of an ambulance. So Jordans friends strapped a piece of plywood tohisback and met paramedics at the nearest paved road. By then, sweat and pain rippled throughJordan'sbody.

You need a helicopter, the paramedics said, calling for a helicopter to airlift him to Barrow Neurological Institute in central Phoenix.

A few hours later, a neurosurgeon brought a stack of X-rays to Jordans hospital room.

Youre paralyzed, he said.

He traced a finger down the scans, following the smooth lines of Jordans spinal cord, until he stopped halfway down. An explosion of bone. The accident crushed his T10 vertebrae. His spinal cord was mangled. An AIS Ainjury.

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The surgeon explained the surgery that came next, the steel rods and screws that would stabilize his spine. Those were standard. But while Jordan was in surgery, he explained, there was something else he could try.

Theres a new procedure. Its never been done, the surgeon said.Theyve had success with animal trials.

Im an animal, Jordan said. Lets do it.

That night in October 2014, Jordan Fallis became the first patient to receive a Neuro-Spinal Scaffold.

Progress came quickly. Within two weeks, the same tingling he felt while lying beside his dirt bike returned. He could flex his thighs, then his hips. Some sensation came back. He regained some control over his bladder. By January 2015, he had blown through AIS B and been upgraded to AIS C.

InVivos stock price spiked, fueled by gushing headlines. For centuries, there had been little progress for spinal cord patients. Even the smallest sign of promise was cause for celebration. Nobody knew if the scaffold had helped, but Jordan wanted to believe it had.

Two years later, the celebration was on hold. Jordans progress had stalled, because at $75 a session he couldnt afford to go to physical therapy anymore.

Before the accident, he was a mechanic, an engineer, a creator. He fixed cars and built dirt bikes from spare pieces. When he needed something, he built it. After the crash he took a job at an auto shop, and in his free time he designed leg braces. He had tried on a few sets, and nothing worked for him. An $80,000 exoskeleton couldnt hold his weight. A $65,000 pair of braces didnt fit. He wanted something faster and lighter, strong enough to hold his weight and affordable for somebody like him.

So he turned to Frank Reynolds. They met shortly after Jordans surgery, and kept in touch as he started rehab and physical therapy. Jordan drew blueprints for customized leg braces. Reynolds left InVivo and founded a new company, PixarBio.

Why dont you just work for me? Reynolds asked, and soon Jordan had a garage full of machinery. He built a robotic knee and had his legs cast in plastic molds that were stacked against the wall.

He spent his days in hisPeoriagarage, working toward a future when spinal cord injuries didnt lock 28-year-olds into wheelchairs for the rest of their lives.While his friends started dirt bike careers in China, Jordan shaped aluminum blocks into artificial joints and covered a whiteboard with physics equations. He learned as he worked. Rock music blared from a stereo system. A TVplayed dirt bike trick videoson a loop.

Jordan Fallis 28, injured his spine doing a motorcycle trick and has worked on ways to improve his mobility.(Photo: Tom Tingle/The Republic)

On the wall behind Jordan's workbenchhung a fuzzy photo of Reynolds' bedroom ceiling, the one he stared at for seven years. Each PixarBio employee had a copy.

And in the center of everything, a dirt bike. Jordan had to sell the one he crashed, butkeptone his father bought back in Iowa. He built hand controls and adjusted the seat so he could ride it without using his legs. A few loose tubes and cords hang from the engine. Once those were connected, he would call his friends and head back to the ramp in the desert, holding on as tightly as he could.

Nicks knee itched. That was new.

It had been two months since the crash he couldnt remember. Two months of paralysis, of lying in bed 21 hours a day, of asking himself how disabled people survived on their own.Nicks doctors moved him to a nursing home because the rehab wasnt progressing as quickly as they wanted.

Two more patients had been given Neuro-Spinal Scaffolds. One in New Jersey, one in California. InVivo announced new clinical trials in Canada and the United Kingdom, testing the scaffold in people with broken necks. Labs across the country made small improvements. There was a possible chemical treatment in Indiana, electrospun nanofibers in New York and a new stem-cell therapy in California.

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Nicks scaffold had already dissolved. He thought the feeling had spread halfway down his calves, but the line seemed to move every day: His thighs tingled, then they stopped. His legs straightened, then they couldnt anymore. He was recovering, then he wasnt.

So he did the rehab and slept in the afternoons, fast-forwarding his life a few hours at a time. Then came dinner, and the nurse made one last sweep through his room before night fell. She squeezed his thighs, his knee, his calves, checking where the line was that day.

Wiggle your toe, she told him.

I wish, he said. But he tried anyway, starting the strange process only paralysis can teach a person. He couldnt simply wiggle his toe, but now told his brain to tell his toe to wiggle.He was sure this is how he had wiggled his toes before, but everything was so much harder now. He tried his left foot. Nothing. He tried his right.

Hey, the nurse said. It moved!

Nick stared down his body. Had the scaffoldworked? He tried again. The signals had fired and the order flew down his neck, his chest, the scar on his back that was still healing,the legs that hadn't moved in two months.

His big toe curled forward.

Nicks doctors upgraded his injury to AIS B. InVivo lauded itself for another successful trial, the seventh of 11 patients to improve in the first month after they received a scaffold. Another month passed, and Nick moved back to the rehab facility.

But he couldnt make the toe move again.

The pain in his back wouldnt fade. Nicks nurses kept rolling him to physical therapy. He felt himself progressing, then worried it may all have been a placebo.

Another patient received a Neuro-Spinal Scaffold. In his garage, Jordan Fallis started another brace prototype with a smaller, lighter joint. Nick left Arizona, squeezing into a too-small airplane seat to go back to Michigan.

His leg muscles sometimes twitched. But he still couldnt bend his toe.

In May, InVivo published a quarterly update on the INSPIRE study. The company reported a loss of $6.4 million and four new patients who had been given Neuro-Spinal Scaffolds. CEO Mark Perrin boasted of the scaffolds early results.The AIS grade improvement rate observed thus far in the INSPIRE study compares favorably to the natural history of spinal cord injury, he said.

But paralysis is unpredictable. In the same report, InVivo announced that two patients who had been upgraded to AIS B had regressed. After six months of progress, both patients were back where they started, withAIS A injuries.

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How a tiny fiber implant is giving new hope to people with spinal cord injuries - AZCentral.com