Just days after her stroke, Lisa Bryant, 51, of North Augusta, sits cross-legged in a bed at AU Medical Center and writes words she wants to say but can’t voice on a notebook. One of them is “DIE.”
Her stroke was noticed Thursday morning because her five-year-old granddaughter, Chloe, answered the phone and told Bryant’s husband she had fallen.
“If it had not been for that, we wouldn’t be having this conversation today,” Edward Bryant said.
While Lisa Bryant got a quick response from an ambulance and received a clot-busting drug and mechanical retrieval of a clot, and has made remarkable progress physically since then, there is little beyond rehabilitation that doctors can offer to improve her symptoms. But that could change depending upon the outcome of a very large clinical trial into a type of stem cell therapy headed up by an Augusta University investigator.
Dr. David Hess, chairman of the Department of Neurology at AU, will head up a Phase III international clinical trial for stroke patients using the MultiStem cell therapy to treat ischemic stroke, the company Athersys said. Unlike the previous Phase II study, which extended the treatment window out to 48 hours after the stroke, the study will focus on 18-36 hours, which Hess believes is the best time window. Athersys is conducting a similar clinical trial in Japan in conjunction with the company Healios.
“That is often what they do,” Hess said. “If you want worldwide registration, you’ve got to do two trials.”
Because of an agreement with the Food and Drug Administration, the company would be cleared to seek approval from the FDA to market it if there are positive results from this study.
Unlike the previous study, this one has a shorter time window because the way the cells are being administered has changed and will not require a cell processing center that added to the delay for many centers in the study.
“They don’t have to be thawed and counted,” Hess said. “So now the preparation time is 15 minutes whereas before it was four hours.”
And that is one of the potentially attractive things about this approach. It can be frozen and on the shelf, available when needed, and can be given to anyone. Once a diagnosis of stroke is confirmed, it could potentially be administered at any primary stroke center. There are 1,100 stroke centers in the U.S. certified by The Joint Commission
“Since you have 36 hours, you could route everybody to get this,” Hess said. “That’s the advantage of it. It doesn’t require tissue-matching, it is off the shelf, it’s fast, it will be faster now with the new formulation.”
Those that got it in the shorter time window in the previous study had fewer deaths and disabilities and less infections and researchers now believe that while there is some effect directly on the brain, the therapy’s main effect could be on modulating the immune system, he said.
“It’s actually promoting the good aspects of the immune system and mitigating the deleterious ones, we think,” Hess said.
The therapy could be preventing the inflammatory response that might harm initial recovery and preventing the spleen from sending out all of those cells and thereby becoming “exhausted,” depleting the immune response and setting the body up for infections like pneumonia following the stroke, Hess said. That is a very different understanding from when he began working on stem cell therapy for stroke patients in 2004.
“You have to look at stroke as a systemic disease, that’s what we’ve appreciated,” Hess said. “When the brain is injured, the whole rest of the body follows.” The cell therapy, given through an IV, helps provide that.
“This actually has a wider target,” Hess said. “Most of it is an indirect effect on the brain.”
He also praised Athersys for sticking with it in pursuing funding for the trials in a skeptical environment where investors and companies fear therapies just aren’t possible.
“So many companies are afraid of it and stay away from it,” Hess said. That is particularly true of the cell-based therapies.
“You don’t see a lot of players doing cell therapy trials in stroke,” he said. “You can count the number of companies on the fingers of one hand.”
Even with positive results, approval could still be years off. For their part, the Bryants have more immediate concerns.
They had just returned from a cruise to the Caribbean when Lisa Bryant had her stroke. And now she is planning on taking another one in a month. While her husband expressed a little reluctance to commit to that, on this issue Lisa Bryant found her voice.
“I’m going,” she said, loud and clear.