Stem-cell injection could be breakthrough for stroke patients
LONDON People who have a stroke could have the chance of a full recovery, thanks to a stem-cell injection that extends the “golden hour” to a day and a half for most patients.
Regulators in Europe and the United States are fast-tracking their approval processes after British patients who tried the treatment 36 hours after a stroke escaped permanent disability.
People who suffer a stroke must get to a specialist hospital within about four hours to begin blood clot-busting treatment, although the best results come in the first 60 minutes.
Most do not make it in time, however, contributing to the almost two-thirds of survivors leaving hospital with a disability.
The new intravenous solution developed in the U.S. simultaneously regenerates damaged tissue, reduces harmful inflammation, and stimulates nerve cells that aid recovery in the brain. Millions of clinical doses can be harvested from a single donation of bone marrow.
A preliminary trial conducted in a handful of patients across the U.K. and U.S. indicated they had a 15 per cent greater chance of making a full recovery after 90 days compared to those on a placebo. The increased likelihood rose to 24 per cent a year after the stroke. Among the people who made an “excellent” recovery were those given the stem cells a day and a half after first showing symptoms.
This is crucial, because many people do not recognize the early signs of stroke, despite years of public information campaigns.
Independent experts have cautioned that more data is needed before hailing a “miracle” treatment. However, the U.S. Food and Drug Administration has awarded the technology fast-track designation, allowing a larger study to begin more quickly, a stance mirrored by watchdogs in Europe and Japan.
Doctors are now enrolling 300 stroke victims onto the new Masters 2 trial. They expect the drug to be eligible for licensing in 2021.
Gil Van Bokkelen, boss of Athersys, which has developed the therapy, said: “If we can expand the treatment window to 36 hours, that’s a time frame that could be relevant to 90 to 95 per cent of stroke patients.
“This could really change stroke medicine as we know it. That’s a big deal, because stroke is one of the leading causes of disability in most countries around the world.”
Professor Keith Muir, a consultant neurologist at Queen Elizabeth University Hospital, said the stem-cell studies to date were too small to draw any firm conclusions.
“If they develop a treatment that improves outcomes for stroke patients and is effective and safe to give within a longer time window, that would be extremely welcome,” Muir said.
It is thought that the new stemcell treatment does not work well after 36 hours, because by that time damaging immune cells have left the spleen and are already heading to the brain, where they can cause considerable damage.
Dr. Kate Holmes, assistant director of research at the Stroke Association in the U.K., is optimistic.
“This research shows that this new type of stem-cell treatment shows some promise in aiding stroke recovery.
“However, this was a small study and we’re looking forward to seeing a larger trial.”
Sunday Telegraph