Stem Cell for Stroke Patients: Safety and Effectiveness – UK, India Research







Stem Cell For Stroke Victims Update (12 August 2013): Aside from the two Indian studies mentioned in our original post below which offer hope that stem cell therapy can help stroke patients, a new study – this time coming from the United Kingdom – suggests that infusing the brain with stem cells may help patients recover after a stroke. The BBC tells us more:

Infusing stem cells into the brain may help boost recovery after a stroke, according to a pilot study by Imperial College London.

Scientists believe the cells encourage new blood vessels to grow in damaged areas of the brain. They found most patients were able to walk and look after themselves independently by the end of the trial, despite having suffered severe strokes.

Larger studies are needed to evaluate whether this could be used more widely.

Now, before we get our hopes up, it is important to note that the above study involved a very small number of patients – only five to be exact – and that the study was not designed to find out if the treatment is effective or not. It’s purpose was only focused on determining whether the treatment is safe and feasible.

As NHS UK rightly points out, “[t]his means we cannot be sure the improvements seen in the patients were caused by the stem cell treatment itself. They could have occurred anyway as a natural path of recovery post-stroke – a point the study authors explained.”

Let’s hope this study, and the Indian studies we reported earlier, will lead to an effective treatment procedure using stem cells for stroke victims.

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Original post date: 20 February 2012

Can stem cell therapy help stroke victims mend and recover? Two Indian studies suggest using stem cell for stroke patients might be a reality in the future.

Many of the fraudulent “stem cell therapies” offered by unscrupulous doctors to desperate patients suffering devastating and incurable ailments end up serving heartbreak, instead. But two recent stem cell therapy trials seem to offer genuine hope to patients who have suffered “brain attacks.”

In particular, intravenous stem cell therapy was found by two studies to be safe and feasible in patients who suffered ischemic strokes. The therapy may also aid in functional recovery after stroke, study authors also say.

The two studies were presented at the American Stroke Association’s International Stroke Conference 2012, held from Feb. 1 to 3 in New Orleans, Louisiana.

But the researchers of the first study were quick to point out that stem cell therapy has a “nonsignificant effect on improving functional recovery after subacute ischemic stroke.” In the second study, however, improvements were found to be significant.

Both studies evaluated the safety and efficacy of administering bone marrow stem cells intravenously to patients who had suffered stokes.

In the first study, 120 patients, 18 to 75 years old, who had suffered a subacute ischemic stroke were injected with mononuclear stem cells from the bone marrow within seven to 30 days after the stroke.

For this study, Dr. Kameshwar Prasad and his colleagues from the All India Institute of Medical Sciences in New Delhi, India, treated half of the patients with stem cells taken from bone marrow from the pelvic bone, harvested and injected into a vein. The other half of patients served as the control group.

The researchers observed the patients for adverse reactions after infusion—and for the formation of tumors for up to one year after the injection was given.

The efficacy of the IV bone marrow mononuclear cell therapy was measured by patients’ ability to perform activities of daily living—as assessed by what is called the Barthel index (BI). The Barthel Index consists of 10 items that measure a person’s daily functioning in daily life—feeding, moving from wheelchair to bed and return, grooming, transferring to and from a toilet, bathing, walking on level surface, going up and down stairs, dressing, and ability to urinate and defecate. The researchers found that 73 percent of patients given stem cells and 61 percent in the control group achieved assisted independence with a BI of ≥60 (P = 0.17).

Using two other scales of the ability to perform daily activities, the Rankin Scale and NIH Stroke Scale, the researchers found similar improvement trends, but noted that these weren’t statistically significant.

Overall, Dr. Prasad’s team found that the IV injection of bone marrow mononuclear cells “was associated with a statistically significant increase in the proportion of dependence-free survival in (only) eight percent of the participants.”

“There’s a trend of better outcome if the number of bone marrow mononuclear cells injected is more than 300 million in the second week, rather than later, but this did not reach statistical significance,” the researchers concluded.

The Indian researchers also found that IV bone marrow mononuclear cell therapy to be safe—it wasn’t associated with any increase in adverse events.

Overall, there were 30 adverse events in the stem cell group reported, versus 35 in the control group. Eight patients in the stem cell group died, while five patients in the control group died. There was also no evidence of tumors found in 79 patients that underwent whole-body PET at the end of one year.

Significant recovery from stem cell therapy
The second study also found that stem cell therapy to regenerate stroke patients appears to be safe. There were no signs of clinical, laboratory or radiologically detected adverse events, the investigators of found. But this time, significant improvement was seen in the ability of patients to undertake daily functions.

Like the first study, this one also evaluated the safety, feasibility and efficacy of a stem cell therapy in stroke patients using the BI and other clinical score, as well as functional imaging. But this time, the study compared the use of autologous mononuclear and mesenchymal stem cells.

For this study, Dr. Rohit Bhatia, Dr. Ashu Bhasin and colleagues administered autologous mononuclear and mesenchymal stem cell IV therapy to 40 stroke patients, recruited three months to one year after a stroke. The researchers of this study were also from the All India Institute of Medical Sciences.

Of 40 patients studied, 14 were given mononuclear stem cells and six received culture-expanded mesenchymal stem cells—or 50 million to 60 million stem cells dissolved in 250 ml saline solution. Both sets of patients received their therapies intravenously over two to three hours. Meanwhile, the remaining 20 patients served as controls.

Compared with the patients in the control group, patients in both stem cell groups experienced significant improvement in their ability to navigate daily life, as measured through the modified Barthel Index (P=.05). Researchers also observed an increase in activity in areas of the brain responsible for movement planning and motor function.

In terms of safety, Dr. Rohit Bhatia and team also found the clinical, laboratory and radiological tests of the stem cell patients to be normal. No deaths or therapy-related adverse events were also reported.

“Autologous intravenous stem cell (mononuclear and mesenchymal) therapy is safe and feasible and likely facilitates behavioral recovery after stroke,” Dr. Bhatia and colleagues conclude in their paper.

According to them the “stem cells act as ‘scaffolds’/cellular mediators for neural transplantation and may aid in repair mechanisms in stroke.”

A cure just around the corner
Writing in the paper presented at the International Stroke Conference 2012, Dr. Bhatia says he believes that a proven stem cell therapy for heart disease patients is just around the corner.

Observing that there are many investigations planned or already underway this year into evaluating the safety and efficacy of stem cell therapies in patients with acute or chronic heart disease, he says, “It’s my opinion that there will be available, proven therapies for patients with cardiac disease, not this year or next year, but within the foreseeable future.”

Even when the two studies were “small studies, as they should be in a first-in-man experiment,” Dr. Douglas W. Losordo, member of the editorial board of Cardiology Today says the positive trends were “notable.”

Dr. Losordo, who isn’t connected to both Indian studies, made his comments in a Cardiology Today article that reported on the new findings.

“For these two studies, investigators took a patient’s own cells from the bone marrow, which is where a lot of stem cells live, presumably did something to purify them and then re-infused the cells into the patients,” explains Dr. Losordo.

“The fascinating part to me is that there was no drug therapy involved; the investigators simply took a cell that the body has already preprogrammed and concentrated a dose of those cells in the region of the damage,” he says. “These data are an indication of the fact that the field is moving along.”

Strokes are a leading cause of death in the United States and the rest of the world. About 17.3 million people died from cardiovascular diseases in 2008, according to World Health Organization—and a huge chunk of this is death from strokes.

Sometimes called a “brain attack,” a stroke happens when blood flow to a part of the brain stops.

When blood flow stops for longer than a few seconds, the brain can’t get blood and oxygen—and brain cells die, causing permanent damage.

Strokes can be either ischemic or and hemorrhagic strokes.

When a blood vessel that supplies blood to the brain is blocked by a blood clot, an ischemic stroke happens. When a clot forms in an artery that is already very narrow, this is what is known as a thrombotic stroke. But a clot may break off from another place in the blood vessels of the brain—or from another part of the body—and travel up to the brain. This is called cerebral embolism, or an embolic stroke.

Ischemic strokes may also be caused by arteries clogged by fat, cholesterol, and other substances that form a sticky substance called plaque.

A hemorrhagic stroke happens when a blood vessel in part of the brain becomes weak and bursts open, causing blood to leak into the brain.

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