MIAMI, Fla., (Ivanhoe Newswire) -- Each year 700 thousand people suffer a stroke in the United States. Until now, the only recovery for paralysis brought on by the stroke was lengthy rehabilitation. Now, a new stem cell therapy is helping stroke patients move again.
James Anderson is a tri-athlete and physical education teacher. He was visiting Florida from Maine when suddenly, “I started to feel a little dizzy a little tingling in my right hand and ah I ended up having a stroke,” James Anderson told Ivanhoe.
James did not respond to clot busting medication or blockage treatments. So he became paralyzed on the left side of his body. Neurologist Doctor Dileep R. Yavatal treated him as part of a clinical trial, where some of the patients were treated with their own stem cells. While Anderson doesn’t know if he was injected with his own stem cells, two months after treatment, Anderson said, "I have had more movement and strength in my legs."
For the clinical trial, stem cells must be injected into the brain no later than two weeks after the stroke occurs. James is now able to move around with a walker, during rehab, and hopes to be able to compete in a triathalon again.
Dileep R. Yavagal, MD, Interventional Neurologist at Miami Miller School of Medicine, talks about the first clinical trial where stroke patients are injected with their own stem cells.
What is your specialty?
Dr. Yavagal: Interventional Neurology.
You are conducting a clinical trial here at Jackson Memorial. What is it for?
Dr. Yavagal: It is the first clinical trial of injecting the patient’s own stem cells.
It is the first?
Dr. Yavagal: It is the first US clinical trial testing the injection of the patient’s own stem cells into the carotid artery going to the brain. These stem cells come from their own bone marrow; we inject them into the brain on the side of the stroke. This is an attempt to improve the patient’s recovery using those stem cells.
You use the stem cells after you inject TPA, which dissolves the clot?
Dr. Yavagal: That is correct. It is not done immediately after, but the time window for giving the stem cells is about two weeks after the stroke; it is a limit of 19 days and in fact, we do not give it immediately after TPA or opening of the arteries, because we want the patient to be stabilized first from their stroke. Then we also have to aspirate their bone marrow once they are stable to harvest the stem cells.
You do that from the hips?
Dr. Yavagal: It is done from the hip bone.
Tell me about your patient James Anderson. He had a stroke on what side? What happened to him?
Dr. Yavagal: James Anderson is a very nice 58-year-old teacher from Maine who was vacationing in Naples and while he was at the rental car counter he suddenly became completely paralyzed on the left side. He was taken immediately to a local hospital where TPA was given, but he did not improve. He was then flown over to Jackson Memorial for an endovascular treatment procedure to open up the blocked artery in the brain that was causing his stroke. His stroke was on the left side; the artery in the brain on the right side was blocked and unfortunately the procedure did not open up the clot, which happens in about 20 to 30% of cases, and he remained paralyzed. He actually had to undergo a surgery to remove the bone on the right side of his head to prevent the swelling from the stroke pushing down on his brain and then he consented to participate in this clinical trial that we are doing called Recover Stroke where we would give him stem cells or do a Sham procedure based on which group he would get randomized to.
When you say Sham, you mean a placebo?
Dr. Yavagal: That is right. Sham is the term used in surgical trials. In this trial, three patients got the treatment; for every three patients, two patients get Sham, In the Sham group, they are brought to the Angio suite and then a simulation of the procedure is done, but the actual procedure is not done and stem cells are not given.
What is TPA?
Dr. Yavagal: TPA stands for “tissue plasminogen activator,” a clot-busting medication. It dissolves the clots that occur in arteries or veins. In stroke cases, it is supposed to dissolve the clot that is blocking the artery in the brain.
This did not work for Mr. Anderson?
Dr. Yavagal: It did not work nor did endovascular treatment, that is the device directly put into the artery to open it; that also did not work. That is precisely why stem cell therapy is really promising, because a number of patients do not benefit or sometimes wouldn't even get the TPA or endovascular procedures. However, stem cells could be treatment that those patients could get as the time window to get stem cell treatment appears to be longer.
How exciting is this that you are able to use the stem cells; and what is his prognosis now that he may have received them?
Dr. Yavagal: It is actually extremely exciting. My own field of research in the lab is looking at stem cells to improve stroke outcomes and the fact that we are now able to do this trial in the US is a big step forward to bring that laboratory promise to the patients. We have about 30 patients, who have been enrolled in this trial, and after a total of 100 patients; we will have some results to see if this therapy can be moved forward to patients.
How does someone get into the clinical trial? What do they need to do?
Dr. Yavagal: They need to be transferred to centers like ours that are participating in the clinical trials and have the infrastructure to both do the bone marrow and do the endovascular procedure.
How are the stems cells given to the patients?
Dr. Yavagal: The stem cells are given via a catheter that is inserted from the groin all the way into the carotid artery. For example, this is the procedure from James Anderson’s acute treatment where we tried to open up the blocked artery, but without being able to say whether he got stem cells or not, if he were to get stem cells; a catheter like this would be brought up. I would inject stem cells into this region so that the stem cells go into the brain that is injured. The catheter would be brought up all the way up to the brain artery and then infused; stem cells would be infused so that they reach directly into the injured area of the brain.
So was it the stem cells that busted the clot?
Dr. Yavagal: No.
How did you end up getting that clot busted up?
Dr. Yavagal: It turned out that after this procedure was done, in the next couple of days, the artery opened up by itself. And yet, that was late. Even though the artery opened up, the brain was already severely injured. That is the limitation of treatments that open up arteries, is that they have to be done extremely urgently and even after they are done extremely urgently, only about 40% of the patients really recover significant brain. Therefore, we need new therapies like stem cells to help that injured brain recover.
So what actually ended up breaking up the clot?
Dr. Yavagal: The body itself has strong substances that break up clots. The TPA remains and that can break up clots. It is just the time sensitive nature where if the clot does not open up within the first few hours then often the brain gets irreversibly injured.
How do the stem cells work, if the patient gets the stem cells, what do they actually do in the brain?
Dr. Yavagal: In the past, it used to be thought that stem cells would go and regenerate into new neurons, the cells in the brain, but it is now becoming quite clear that especially stem cells that are from the bone marrow, play more of a nursing function where they stimulate the body’s own mechanisms of repair and enhance them and make them work harder to get the repair done much better than if the stem cells were not there. They act like small factories secreting a number of substances that stimulate the brain surrounding the injured environment and help with recovery.
What kind of recovery has Mr. Anderson had?
Dr. Yavagal: Mr. Anderson has shown remarkable recovery. Again, we do not know what he got, but despite that he is now walking with a walker within about 6 weeks from his stroke. His arm is still paralyzed, but he is able to use a walker with minimal support to take steps; so that is very exciting and in a year, we will find out if he got the stem cells and if in comparison to the patients who got Sham whether he did better.
Okay, so he will continue to get better?
Dr. Yavagal: Yes. That is typical for most stroke patients to show some recovery and the idea is that these stem cells, if he got them, would enhance that recovery.
What about doctors who are not using the stem cells, how will this benefit them in the future? How will that benefit other doctors around the country to use the stem cells?
Dr. Yavagal: This trial will lead us to the next study where approval can be sought for this kind of therapy. And these 100 patients will count towards that approval and such an approval would allow all doctors, not only in the US, but around the world to use this therapy.
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