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CChheennDDeerr--cchheerrnngg11,,22,,3, Shyu Wei-cherng1,2,4, Chao Der-yang1,2,3, Lin Shin-3
zong1,2,3
China Medical University and Hospital Center for Neuropsychiatry1, Center for stroke2, Dep. of Neurosurgery3, Dep. of Neurology4
使
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第
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一
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報
告
告
陳 陳德德誠 1,2,3 徐偉成 1,2,4 周德陽 1,2,3 林欣榮 1,2,3 誠 中國醫藥大學及附設醫院 神經精神醫學中心 1 腦中風中心 2 神經外科部 3 神 經內科 4Purpose
There are no effective and aggressive methods for chronic stroke patients. Stem cell therapy rising promising hope in many neurological diseases. We try to transplant autogenous CD 34+ stem cell into chronic stroke patients and test their effects and safety.
Materials and Methods
From Aug. 2006 to Jun. 2007 there were seven chronic stroke male received the transplantation. One patient found terminal oral cancer two months after operation and he was excluded from the study. All the patients received subcutaneous granulocyte colony stimulation factor (G-CSF) injection for five days. Then blood electrophoresis performed on the sixth days and CD34+ stem cell were extracted at GMP lab in the same day. Stereotactic transplantation procedures were performed in the same day evening. All the patients received imagine study (MRI, FDG-PET, Brain perfusion) and functional assessment (NIH stroke scale, European stroke scale, BARTHEL scale, Mini – Mental state examination, European motor scale, Gait analyzer, Balance test) pre and post operation regularly as schedule.
The phase II clinical began Aug 2009 and scheduled fifteen transplant patients with the same number control patients with comparison.
Results
1. Total six patients age from 46 to 70 years old (55.5±8.8) were included. 2. Every patient received 3-8 x 106 (6.2 ± 1.9 x 106) CD34stem cell
3. The second patient developed subdural effusion and the fourth patient suffered from stitch reaction. Others did not have major complications 4. The primary endpoint(NIHSS, ESS, EMS and BI) got 65% improvement in
three patients and 30% improvement in other three patients
5. In the secondary end point (FDG-PET and TMS)，in FDG-PET showed activated neuronal activities in peri-infarction areas. The TMS showed
reappearance of neuronal electricity in lesion limbs
6. Regeneration of the cortical spinal tract were found in some patients
Conclusion
1. There is no major complication after the operation in these seven patients. 2. The two years follow up results showed improved neurological functions
and cerebral blood flow in ischemic areas
3. Younger patients had better improvement rate than older patients 4. The stereotactic transplantation is a minor surgical procedure and its
complication rate is low with good training and planning.
5. Phase II study including operation and control groups with larger number size could provide more results that will be benefit to future cell therapy.
