Study: New treatment could help stroke patients
By Lynne Terry | The Oregonian/OregonLive
April 06, 2017
At 45, Sharon Thomas collapsed with a massive stroke that left her unable to walk, talk or swallow.
Physicians predicted she'd be an invalid for the rest of her life. But today, she's back hefting 30-pound sandbags at work and playing basketball for fun.
Thomas is among several dozen people who have responded surprisingly well to a new stroke treatment in a clinical trial at Oregon Health & Science University and about 30 other sites in the United States and Britain.
Doctors treated patients with an infusion of stem cells grown from adult bone marrow. Unlike other cells, stem cells can become specialized to repair organs and tissue.
They offer promise to treat a range of conditions like diabetes, macular degeneration and spinal cord injuries. And now strokes - the fifth leading cause of death in the country and the top cause of adult disability.
"This really could vastly increase the number of patients that we could help after a stroke," said Dr. Wayne Clark, director of the Oregon Stroke Center at OHSU.
The study was funded by Athersys, Inc., the company that makes the stem cells.
The randomized, placebo-controlled trial enrolled nearly 130 people between 18 and 83 years old at 33 sites. Just over 30 were treated at OHSU. The patients were enrolled after a severe stroke caused by a blood clot in a vessel that supplies blood to the brain.
Blood clot strokes tend to be devastating, often leaving patients heavily impaired, Clark said. A main treatment now is a clot-busting drug - tPA or tissue plasminogen activator. But it has to be given within three hours of the stroke.
Only 5 percent of patients qualify because the rest don't get to the hospital in time, Clark said.
But the stem cell infusion was effective up to 36 hours later, the study showed.
Patients received an infusion of 1.2 billion cells, originally derived from a volunteer who gave a bone marrow sample. The cells were then grown in a lab like a crop of vegetables. They've been checked and rechecked for pathogens, Clark said, to ensure their purity.
The stem cells didn't appear to cause any side effects. Not only that, the treated group suffered about 50 percent fewer infections than the placebo patients.
The infusion was given over a few hours, allowing the cells to stream to various parts of the body, including the brain. The trial researchers don't think they became neural cells but rather changed the environment in the brain to make it more likely to regenerate.
"We think we're making an old person's brain act like a young person's brain so they can have a better recovery," Clark said.
Many stroke studies stop after three months. This trial followed patients up to a year.
The results were exciting, Clark said.
Just over 70 percent of the patients had a full or excellent recovery, compared with about 40 in the placebo group.
Dr. Steven Cramer, clinical director of the stem cell research center at the University of California, Irvine, reviewed the study for The Lancet Neurology, where it was published. Cramer called the study an "important step forward," noting that stem cells are an attractive option.
"New therapies are needed that improve outcomes in a large proportion of patients with stroke," Cramer wrote.
Thomas, who lives in Medford, was among the fortunate.
Her stroke struck one night in April 2013 while she was clearing dishes after dinner at her parents' house near Roseburg.
"The glass fell out of my hand," Thomas said.
She picked it up but it dropped again. She collapsed into her husband's arms.
"I could not stand, swallow, read, write or talk," she said.
She was initially treated at Mercy Medical Center in Roseburg. Physicians treated her with tPA but it didn't dissolve all of the clot. She was put on a medical airlift to OHSU.
A doctor told her husband she wouldn't walk or talk again. OHSU asked if she wanted to be in the trial and she agreed. She had no idea how massive her stroke was.
Three days after the infusion she could walk without assistance. But she was far from recovery, unable to talk or swallow. She ate only applesauce for three months.
"I had to be really careful of what I ate and how much I ate of it," she said.
The stroke affected her right side.
Though she still couldn't speak at the six-week mark, Thomas returned part time to work as a traffic control supervisor at Kogap Enterprises, an excavation company. At two months, Thomas was back full time. For her job, she maps routes at work sites, drives a dump truck and sets up signs, securing them with sandbags.
Though her right side remained weak, she was stronger than most women her age after years of working out and weight-lifting.
She could load equipment but spent months relearning how to perform precise movements like applying mascara. She underwent speech therapy for a year and talked in a whisper for much of that time.
Even today, her voice isn't the same. But she continues to get better.
"I see improvement about every month," Thomas said.
To her family, friends and colleagues, she seems fully recovered.
"I haven't seen miracles happen," Thomas said. "Maybe this is a miracle."
A new trial will start this summer to confirm the results, Clark said. It will continue for a year and a half. The treatment will be given only to patients within the first 36 hours of a stroke.
If the cells again prove effective, the treatment could end up being approved by the Food and Drug Administration, Clark said.www.oregonlive.com/health/index.ssf/2017/04/study_new_treatment_could_help.html