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By Jacqueline Lisk
| July 3, 2020
Phil Green is a former collegiate football player, a husband, son, and father of four. When he was 48, he was diagnosed with ALS. This nervous system disease weakens physical function overtime, and the average life expectancy is two to five years from the time of diagnosis.
Green says his diagnosis was not a shock: he had been getting progressively weaker for months. “In fact, my diagnosis gave me the freedom to move on and start my new journey,” he says.
Fortunately, Green learned he was one of 200 people who qualified for the BrainStorm Cell Therapeutics NurOwn clinical trial. At that point, his hands were so weak, he struggled to button his shirt.
NurOwn is an investigational cellular therapy that takes mesenchymal stem cells (MSCs) from patients (autologous MSCs— cells produced from a patient’s own bone marrow-derived MSCs), which can generate various cell types. These MSCs are then converted into a cell-type — called MSC-NTFs — that produce neurotrophic factors (molecules which promote nerve tissue growth and survival). NurOwn is currently in phase 3 clinical trial, and Massachusetts General Hospital and University of Massachusetts Medical School are both participating in the research.
Over 11 months, Green endured a bone marrow harvest and seven lumbar punctures. In September 2019, he received the last of three stem cell transplants into his spine. When the trial ended for him two months later, he was still cutting his own food and dressing himself.
Green is hopeful the treatment will receive FDA approval within the next seven months or so. Until then, he tries to find access to experimental therapies in ALS using expanded access or compassionate use.
Clinical trials like the one Green participated in and seeks are experiments done in clinical research to generate data on safety and efficacy. According to Clinicaltrials.gov, there are more than 300,000 research studies taking place across all 50 states and 214 countries. For the medical community, clinical trials are a necessary step in receiving FDA approval needed to widely distribute treatments. For clinical trial participants, these experimental therapies can be life-saving.
It was also an experimental medical treatment that saved John Haverty his leg. Shortly after having knee surgery about 12 years ago, Haverty fell on the ice and opened his incision, which then became infected with Klebsiella pneumoniae bacteria. For 11 years, his medical team at the Mayo Clinic tried different antibiotics and surgeries to eradicate the infection, Haverty endured 17 surgeries in all, and reached a point where the only approved option left was to amputate his right leg at the hip.
“I was pretty disheartened. I went through a lot of depression. My wife and I were even shopping for wheelchairs,” he remembers, “I am an old motorcycle rider, so I wanted something cool — something with flames on it — but nothing like that seemed to exist.”
At the brink of giving up, he turned to internet research. He was aware of phage treatment [the therapeutic use of bacteriophages to treat bacterial infections like Haverty’s], and he happened across Maryland-based Adaptive Phage Therapeutics. The company responded quickly to his email and began working with his Mayo-Clinic based physician. Upon approval of an emergency application to the U.S. Food and Drug Administration, Adaptive Phage supplied a course of phage therapy.
Haverty saw incredible results over one weekend. He regained full use of his leg and experienced no side effects. It has been almost a full year since the start of his treatment, and he feels great.
“I was given a whole new leg — more so than was expected, because no one knew what the result would be. It turned out we hit a home run with phage therapy. I look at my leg now, and I think, ‘This is just the most amazing thing that ever happened,’” he says. “My wife and I still can’t believe it. Unless you see the scar, you would never know I was in that situation.”
Haverty believes phage therapy has the potential to save millions of lives worldwide. Research is underway at locations across the U.S., including the Mayo Clinic, Yale Medicine, and UC San Diego School of Medicine.
His story, and Green’s, exemplify the potential of new medical treatments, and the tireless work scientists and researchers put in every day to improve our ability to treat and cure disease.