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2018 AANS Annual Scientific Meeting
568. Phase I clinical trial of intracerebral trans ...
568. Phase I clinical trial of intracerebral transplantation using BMSC against acute ischemic stroke
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Video Transcription
clinical trial of intracerebral transplantation using bone marrow stromal cell against acute ischemic stroke, the rainbow prognosis. Thank you very much. I'm Dr. Kawabara from Japan. We would like to present our phase one clinical trial using autologous BMSC against acute ischemic stroke. As all of you know, there are several clinical trials already being published. However, the study design vary between the trials. And it is still unknown what is the most safe and effective method. So from our basic research, we have found that the BMSC with no gene modified, the dose of 20 to 50 million, and the intracerebral route at the subacute route, with assessment of not only the motor function, but also the MRI, PET, and spec, will benefit the patient. So we have started our phase one clinical trials. You can find a protocol in this article. And I, myself, is the PI for this clinical trial. And what is special about this trial is that we are only recruiting the patient at acute ischemic stroke with a severe neurological symptom, which is at day 14 after the ischemic insult, the patient shows, almost most of the patient shows a complete hemiparesis. And what is new about this procedure is that we do not use FBS to expand the stem cells. We use a platelet lysate from the healthy volunteer. And we also use the stereotactic transplantation. And cell tracking is also used by using the spile. This is a magnetic material. You can see on the T2 star in the MRI. And we have done three patients so far. And this is the first patient. It's the 74-year-old Lachner stroke with a BAD, branch arterial method disease. And we did the operation 52 days from the onset. And as you can see, the patient has a stroke. And we have chosen the white matter as a transplantation site. And we transplanted two multiplied by 10 to seven cells. And this is how we did our surgery, that we made a burr hole on the skull and we injected the stem cells for five minutes of time. And this is the result of the patient. As we see that the T2 star, as indicates the stem cell, is decreasing over the course of time. And we saw very little signal on the surface of the infarction as the cells migrate to the ischemic site. Same as our animal study. And the patient's modified ranking scale does not change. But the FIM and the burr hole index seem to be increasingly improving, even through the 13, three months and the six months after the surgery. The second patient is a cardioembolic stroke and a post-thrombectomy. And we have also done the same procedure to the patient. And the patient is also showing mild improvement of the neurological symptom. The third patient is the severest patient with the arteriosclerotic stroke. And we have just finished the surgeries. So we are not sure that it will be good for the patient. But we see that the stem cell is also decreasing over the course of time. So we have presented our preliminary data of our phase one clinical trial using autologous BMSC for intracerebral injection for patient with acute ischemic stroke. We will further investigate the safety and the effectiveness of this trial. Thank you very much. Thank you.
Video Summary
In this video, Dr. Kawabara from Japan discusses a phase one clinical trial using autologous bone marrow stromal cells (BMSC) for the treatment of acute ischemic stroke. The study aims to determine the most safe and effective method for this type of treatment. The trial involves using BMSC with no gene modification, a dose of 20 to 50 million cells, and the intracerebral route at the subacute stage. Assessment of motor function and various imaging techniques such as MRI, PET, and spec are used to evaluate the benefits to patients. The trial has recruited patients at day 14 after the ischemic insult, who show complete hemiparesis. The procedure involves using a platelet lysate instead of FBS to expand the stem cells and utilizes stereotactic transplantation. Cell tracking is carried out using magnetic material visible on MRI. The video presents preliminary data from three patients in the trial, showing a decrease in the stem cells over time and some improvement in neurological symptoms. Further investigation is required to assess the safety and effectiveness of this approach. The transcript does not mention any credits granted.
Asset Caption
Masahito Kawabori (Japan)
Keywords
autologous bone marrow stromal cells
acute ischemic stroke
clinical trial
intracerebral route
motor function assessment
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