In March of this year, researchers at the University of Texas Medical School at Houston enrolled the first patient in a Phase I safety trial to test stem cell therapy in stroke patients. Usually, in Phase I trials, healthy volunteers are enrolled to assess the safety of a drug or a therapy. In this case, the participant is a stroke patient. The 61-year old stroke survivor arrived at the hospital more than 3 hours after the onset of the symptoms, thus making him ineligible to be treated with tissue plasminogen activator (tPA). According to the American Heart Association, tPA is a thrombolytic agent (clot-busting drug). It is approved for use in certain patients having a heart attack or stroke. The drug can dissolve blood clots, which cause most heart attacks and strokes. tPA is the only drug approved by the U.S. Food and Drug Administration for the acute (urgent) treatment of ischemic stroke. However, tPA is a time-sensitive treatment that can only be effective when administered within 3 hours of symptom onset. Stem cell therapy might be a less time-sensitive alternative to tPA.
Here is how the stem cell therapy works:
Stem cells were harvested from the bone marrow in the iliac crest of the patient’s leg. The purified cells were then administered intravenously back to the patient several hours later. Because they were his own stem cells, the problem of rejection is very unlikely to occur.
The Phase I safety trial, funded with a pilot grant from The National Institutes of Health and support from the Notsew Orm Sands Foundation, will enroll nine more patients who have suffered a stroke and can be treated with the stem cell procedure within 24 to 72 hours of initial symptoms.
Research using lab animals has shown that stem cells given after a stroke enhance healing of the damage brain. Stem cells seem to have some kind of “guidance system” to find their way to the area of injury. Stem cells promote healing, not by creating new brain cells, but by helping the repair processes and reducing inflammatory damage. Animal research showed that the effects of the therapy can be observable within a week.
So far, the patient has been making a lot of progress. However, it is too early to tell whether the improvement can be attributed to stem cell therapy or some other factors. The long-term effects of the therapy also needs to be investigated
According to lead researcher Dr. Sean Savitz,
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