LONDON: Stroke patients who suffer partial paralysis, become handicapped and lose the ability to carry out simple day-to-day activities such as taking a shower or changing clothes can now hope to be cured with their own stem cells.
Researchers have reported encouraging interim data from the world's first clinical trial examining the safety of neural stem cell treatment in stroke patients, ahead of an application for Phase II trials.
The trial saw brains of stroke patients injected with neural stem cells to test the safety and tolerability of the treatment.
Results presented to the 22nd European Stroke Conference in London on Monday found that most of the five patients injected with stem cells had experienced sustained modest reductions in neurological impairment compared with their pre-treatment baseline performance, accompanied by improvement in abilities to undertake day-to-day tasks.
Professor Keith Muir of the University of Glasgow, who is heading the trial at the Southern General Hospital, Glasgow, reported that data from the first nine patients treated had shown no cell-related or immunological adverse affects. A further two patients have been treated since the data were collated and the trial is now drawing to a close, with full results due to be published next year.
Meanwhile, plans are proceeding for a Phase II trial that will examine the efficacy of stem-cell treatment in stroke patients and an application is expected to be submitted to the UK regulatory authorities in July. If approved, the Phase II trial is scheduled to commence later this year. The Phase II trial will be a multi-centre one involving about 20 patients initially, all of whom will have suffered a stroke within a few weeks.
"The evidence of functional improvement requires further investigation in a suitably designed Phase II efficacy study and we look forward to being a principal clinical site in that study when it commences," said Professor Muir.
This breakthrough has the potential to drastically change the way stroke patients are treated in India, where stroke is a major cause for loss of life, limbs and speech. The Indian Council of Medical Research estimates that in 2004 there were 9.3 lakh cases of stroke and 6.4 lakh deaths due to stroke in the country, most of the people being less than 45 years old.
Dr Kameshwar Prasad from AIIMS said the number of deaths and persons disabled due to stroke was rising in India. Increasing life expectancy at birth, rising urbanisation, changing lifestyles and rising stresslevels are bound to increase stroke cases. Those with high blood pressure, diabetes and high blood fat (cholesterol) are especially at risk. The most important of these risk factors is high BP. In India, more than 16% of people above 20 years of age suffer from high BP.
A small-scale study conducted by Delhi's AIIMS had found that about 60% of 12 patients, in whose cases stem cells taken from the bone marrow were injected back into the antecubital vein (in the forearms, near the elbow), were able to carry out activities such as walking, using the toilet, taking a bath, dressing and eating independently within six months. This increased to 70% within a year. None of these patients had been able to carry out such activities at the beginning of the study. But the same was not true for the three equally serious stroke patients who did not receive stem cells during their treatment. While 33% were able to carry out these activities at the start of the study, the figure increased to only 50% in a year.
"Around 50% in the stem cell group became free of deficits like weakness of one limb and inability to walk as against 30% in the control arm," Dr Prasad said. "The stem cells had excellent safety profile. After carrying out PET scans and MRIs thrice in a year on patients who received stem cells, we found no side-effects. This study shows that stem cells are a safe and feasible therapy in acute stroke. This holds promise and needs to be confirmed in a bigger study."
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