Kade Simmons

Read a Testimonial from Kade's Neurologist

Kade's Story

The Estate of Kade Simons is a Petitioner represented by his mother Kandy Simons. Kade received three doses of NurOwn in Phase 3a trial at Mayo Clinic with neurologists Anthony Windebank and Nathan Staff. NurOwn worked on Kade and he could feel the impact almost immediately. But he was not one of the ten people chosen to receive additional doses via EAP.

Kade was diagnosed with juvenile-onset ALS (jALS) at just 21 years old. He was also a carrier of a variant of uncertain significance (“VUS”) in the SETX gene (c.3187A>G). Kade’s variant is not listed on ClinVar, but other SETX variants are associated with juvenile-onset of ALS.

When his mom was pregnant with Kade, they lived in Cottonwood Canyon, Utah where his dad played for the Twins’ Triple-A club, the Salt Lake City Buzz. Kade was a natural athlete from the moment he was born. He was walking by seven and half months and hitting the ball off the T by 2 years old. Kade spent his youth rolling around on the grass at minor league baseball fields where his dad played for eleven years.

Like his Dad, Kade was a multi-sport athlete. He wrestled, played wide-receiver and cornerback in football, and centerfield in baseball. Before the eighth grade, Kade had already sustained stingers and two concussions playing football. After that he focused on baseball year-round and in baseball, he excelled. In high school, Kade was on the Oklahoma state All-Star team, ranking 14th overall and 4th in Oklahoma among all outfield prospects. Ambidextrous, Kade batted left and threw right. Kade’s speed from home-to-first was considered “elite.”On the diamond, Kade was the lead-off hitter and known for lightning fast speed and his laid out, diving catches. But that rough and tumble athleticism also led Kade to multiple injuries, and dozens of broken bones, including a spontaneously fractured right humerus when he was throwing a baseball from centerfield in the spring of his freshman year. He also sustained multiple concussions and repeated sub-concussive hits throughout his career.

Playing his second year of college baseball, Kade’s first symptoms were on the diamond, just as it had been for Lou Gehrig. His bat speed slowed and his timed speed from home-to-first base was one-half second slower. He initially noticed onset in his dominant right hand and right leg, and by May it started to impact his speech. His initial symptom onset was in February 2018; he was diagnosed in December 2018, and then received 3 doses of NurOwn in July, September and November of 2019.

Before NurOwn, Kade was a “fast progressor.” NurOwn changed that trajectory.

Before the NurOwn trial screening, Kade had lost 14 points in just 8 months (1.75/month).
During the NurOwn trial, his losses slowed to 3 points in 6 months (0.5/month).
After receiving just 3 doses in the NurOwn trial, his overall progression slowed to approximately1 point every 6 months (0.16/month) – a 91% slowing versus before NurOwn.

While not “progression-free survival,” this marked slowing in lethal progression was life-changing.Kade could tell immediately that NurOwn was working. Kandy’s Public Comment hyperlinked to two videos where Kade commented on how he had regained function after just one NurOwn injection. In the first video in June 2019 – the day after his first dose -- he spoke about how his toes were “popping up,” meaning his foot drop was improving. In the second video a few weeks later, he spoke about having to adjust to the increased strength in his previously weakening legs. Neither of those improvements resulted in any change in his ALSFRS-R score of ‘3’ as he still had “early ambulation difficulties.” Kandy’s Public Comment and testimony also shared other ways that NurOwn improved how Kade felt and functioned.

NurOwn Improved How He Functioned:

Legs were stronger
Able to climb stairs to his bedroom
More balance when standing
Able to effortlessly cross one leg over the other
All gross and fine motor movements required less effort
Foot drop improved with “toes popping up easier”
Speech improved, and his words were easier to enunciate
Grasped utensils and could direct them to his mouth without missing
Texting was easier and writing remained legible

NurOwn Improved How He Felt (nothing on ALSFRS-R measuring symptoms)

Muscle twitching stopped immediately after injection
Significantly less spasticity
Less clonus & cramping
Full body improvements
More ROM, loose & limber
“Everything felt better”

Kade and his family weren’t the only ones to witness these improvements. Kade was seeing a physical therapist, John Carey, who specialized in treating collegiate and professional athletes. John didn’t know Kade had participated in a clinical trial. But when Kade returned in August 2019, John remarked that Kade’s entire body was more stretchable, had more ROM and less spasticity.

Perhaps most importantly, NurOwn made a significant difference in Kade’s respiratory function. Up until the day of his death, Kade didn’t need a bi-pap to breathe. He slept lying flat on his back (4/4 points on the ALSFRS-R). NurOwn didn’t only impact Kade’s phrenic nerve and diaphragm function, it unexpectedly improved his lung function. Kade had been a lifetime asthmatic, in and out of ERs since he was one-year-old. He regularly used albuterol and nebulizers. He needed albuterol so often that he kept it in his gym bag and in the dugout. But after receiving three doses of NurOwn in 2019, he seldom needed his albuterol again. Over the ensuing 5 years until his death in 2024, Kandy estimates Kade only needed his albuterol a total of 5 times. NurOwn’s plausible mechanism of action also had a profound systemic biological impact on his asthma too.

On September 28, 2021, Kade had his first and only visit with Dr. Frank Sorhage, a pulmonologist at the Holy Cross ALS Center of Excellence. Dr. Sorhage has 30 years of experience in critical care and has treated hundreds, if not thousands, of people with ALS. Upon assessing Kade’s breathing function, Dr. Sorhage proclaimed: “Are you sure you have ALS? Your breathing is not typical for someone who’s had ALS for 3 years.”

Ultimately, Kade decided he didn’t want to attend a multi-disciplinary clinic. He didn’t want to go to be reminded how fast he was dying. He was an athlete who knew his body. He didn’t want a doctor to tell him what he already knew. He wanted a neurologist to give him the only thing that would make a significant difference in how he felt and functioned. If he couldn’t get more NurOwn, he didn’t want anything else.

But Dr. Sorhage was right. Kade lived 78 months without using NIV. This is over 5x longer than the Time-to-NIV natural history for fast progressors.

Despite the massive amount of evidence that NurOwn worked on Kade, Kandy Simons was only given 3 minutes to speak at the AdComm to advocate for her son’s life. Kandy closed by pleading with the FDA.

“Four years ago, Kade gave his body to advance ALS science. It would be inhumane to now deny Kade’s access to this drug because the FDA approval process didn’t act as quickly as ALS is killing him... No mother should have to watch their child die when we believe a treatment is available to help him live a life worth living.”

Inhumane it was. Three months after this plea, Kade learned he did indeed receive NurOwn – just as he and his family had believed from his very first injection. Tragically, Kade died waiting for more NurOwn -- just six days before his 27th birthday.

Kade lived 78 months both NIV-free and trach-free. That is over 5x longer than Time-to-NIV natural history for fast progressors. It is also 48 months longer (2.5x) than the natural history for median trach- free survival in ALS. NurOwn gave him that chance.

Up until the AdComm, the day Kade was diagnosed with ALS was the worst day in Kandy’s life. But the day of the AdComm was the second worst day. When she told Kade the news about the negative AdComm vote, Kandy saw the light go out in his twinkling blue eyes. He knew at that moment that he was never going to get NurOwn. After that, emotionally, Kade was ready to die.

Kandy did everything she could to keep Kade alive, but the FDA didn’t do all it could.

So instead, Kade asked his Mom to arrange Medical Assistance in Dying (MAiD). A mother was forced to help her 26-year-old son make arrangements to end his life because the FDA wouldn’t give him the therapy that he KNEW extended his life. Under MAiD law, there are multiple requirements. One is that you must sign yourself attesting that this is your choice. But Kade couldn’t sign his name so he held a Sharpie in his mouth to sign the “X.” He also needed two witnesses to sign so Kade chose his Aunt Kathy and his Granny Kathy. But Kade didn’t want them to feel the guilt of attesting to his suicide.

So, with wisdom far beyond his years, and in an ode to Lou Gehrig’s speech, Kade typed this message using his eye gaze:

“I have fought this for as long as I can. I am never comfortable or able to sleep well, and I feel like I am buried alive all the time. It’s no way for my parents or my brother to live – and not for me either. Just be happy that I can painlessly choose where and when I want to end my life and also be happy that we all get to say goodbye to each other because very few people get that luxury in life. I will be with you guys always, and in a blink of an eye, we will all be together in a way better place. We are all good and loving people and will all go to the same place in the end. I‘ll get to meet Grandpa Jim and Grandpa Bill, Brucie and Memaw Kat, and many other people. Like it says in Shogun: ‘We live and we die. It’s what we do in the middle that counts.’ I lived every day like it was my last. I got to do and see more than most people do in ten lifetimes. I am the luckiest kid in the world.”