Terri Pickering Saenz

Terri's Story

Petitioner Terri Pickering Saenz was a participant in the NurOwn Phase 2 trial with Principal Investigator Dr. Nathan Staff at Mayo. She received 1 dose of NurOwn in July 2015. The trial was unblinded in 2016 and Dr Staff sent a letter confirming that she received NurOwn. In the unblinding letter, Dr. Staff also shared: “You may already know that the results of the Brainstorm NurOwn study were favorable.”

Terri, like many other Phase 2 participants, is adamant that NurOwn worked on her. Like the people in Phase 3 and EAP, NurOwn halted Terri’s ongoing paralysis and she had years of slowing of her symptoms.

In her Public Comment to the NurOwn AdComm, Terri shared details about her progression after NurOwn Her ALSFRS-R score stabilized during the trial in the low 40s and 17 months later in October 2016, her score was still 39. She was only losing about 1 point every 4 months instead of the average of 1 point every month. In the 15 months after that, her progression returned to normal in both upper and lower limbs. But thankfully, her breathing and swallowing have progressed much more slowly. This is surprising as slurred speech was one of her first symptoms in 2014. At the time of the AdComm, she could still speak and people understood her. Almost 9 years after diagnosis, Terri only used a bipap to breathe at night.

Terri was diagnosed with ALS at the age 47, on January 8, 2015:

“My symptoms began in March 2014 with muscle twitching all over my body. Later that summer I noticed my non-dominant left hand, arm and shoulder were weaker. It was hard to open packages. I began choking on my almond snacks... My legs and my breathing were weaker. While running a 5K in October, I noticed I didn’t have any “gas in the tank”. I was having trouble pushing myself to go quicker and unable to breathe properly. Around the holidays, my slurred speech began to be more noticeable and that led me to seek medical care.”

With bulbar and respiratory onset accompanied by onset in other regions, the natural history indicates Terri should have been a fast progressor. But after the Phase 2 NurOwn trial, she wasn’t.

Terri’s one and only dose of NurOwn was on July 3, 2015. When she began the trial, Terri was earlier in progression than the average phase 2 participant. She was in the trial just six months after diagnosis, whereas the average in the trial was nine months. The baseline score in the trial was 38, and Terri’s was 43. Just before the holidays, she started to feel NurOwn wash out and her progression ensued. Then, in the first 9 months of 2016, her score again stabilized at 39. Her breathing, speech and swallowing remained stable. Five months of progression-free survival followed by 9 months of progression free-survival!

As 2017 and 2018 came and went, Terri progressed from a cane to a rolling walker. Her upper limbs were most progressed, and she needed assistance to lift utensils to her mouth. But her breathing, speech and swallowing remained stable.

In 2019 and 2020, Terri began using a power wheelchair, but she could still transfer by walking with assistance. She used that power wheelchair to “lead” her son during the Mother-Son dance at his wedding. And just as before, for those two years, Terri’s breathing, speech and swallowing remained stable.

With the passing of two more years through 2022, Terri’s progression was more noticeable. Her upper body weakened and she needed assistance to eat. She had a slight decline in breathing, speech and swallowing, but still was not using any NIV to breathe – almost 9 years after symptom onset and eight years after diagnosis. And because of this blessing of strong respiratory function, she and her family were still taking their annual trip to Mackinac Island.

Since the AdComm, Terri continues to celebrate life's blessings. She was here as her youngest son brought his first child into the world. She danced again at a wedding; this time with her oldest son.

One decade after she received NurOwn at Mayo, we believe Terri Saenz is the only remaining survivor from the Phase 2 trial. Terri’s NurOwn journey is notable for several reasons:

Living Trach-free 125 months post-diagnosis - 6.9x 4.6x longer than median TFS
Living Trach-free 134 months post-symptom onset - 4.6x longer than median TFS
Bulbar and respiratory onset with upper limb onset which usually typifies a “fast progressor”
Yet her breathing, speech and swallowing remained stable for approximately 7 years
15 months of significantly slowed progression, down to 1 point lost every 4 months
4 months of progression-free-survival after dosing

But life has gotten harder since the NurOwn AdComm. For all those years, Terri’s breathing, speech and swallowing remained stable. Now they are not. There are consequences to the FDA’s Type II error.

In May, for ALS Awareness Month, Terri “celebrated” by spending a week in the ICU with pancreatitis. Don’t ever let anyone tell you ALS isn’t painful. And her husband Jeff was by her side. On May 22nd, Jeff updated all her friends on social media about Terri’s ICU admission:

“All settled in at UofM. Hasn’t been a fun day. Started with another CT scan at St. Joe, definitely not enough people to handle an ALS patient transferring to the table. Got her all prepped and took an ambulance ride to UofM. Unfortunately, the best thing for her safety, and wear and tear on her body, was getting put in a bed. Remember she has been full-time in her wheelchair for the past 6+ years. Communication has been very difficult trying to get her eye gaze working adequately.... One of the hardest things I’ve ever had to deal with.”

Living a decade with ALS, Terri is already beating the odds. She is not only living but she is still trach- free. But she cannot continue to wait for yet another Phase 3 trial. With NurOwn she could continue to take the family’s annual trips to Mackinac Island.

Terri closed her AdComm Public Comment with this question and photos from the family’s 2016 trip to Mackinac: “I was so filled with hope after Nurown changed how I felt and functioned. But I wonder... What if I had continued to get Nurown in 2016? Today I still have hope that the FDA can End ALS.

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