Y-3 Injection Through Skull Bone Marrow in the Treatment of Acute Malignant Middle Cerebral Arter… (NCT05849805) | Clinical Trial Compass
CompletedNot Applicable
Y-3 Injection Through Skull Bone Marrow in the Treatment of Acute Malignant Middle Cerebral Artery Infarction (SOLUTION)
China20 participantsStarted 2023-04-17
Plain-language summary
The mortality of malignant middle cerebral artery infarction (mMCAI) is up to 80%, while current available treatment is limited. The purpose of this study is to explore the feasibility, safety and efficacy of Intracalvaria bone marrow injection of cytoprotective drug Y-3 in mMCAI patients with contradictions of reperfusion therapy or poor reperfusion outcome.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓.18-75 years old; 2.No gender limitation; 3.Pre-stroke mRS score \<2 4. Randomization can be finished within 24 hours of stroke onset (onset time is defined as last-seen-well time) 5. Ischemic stroke in the middle cerebral artery(MCA) territory meeting the following characteristics: A. 15\<NIHSS≤30 B. Imaging within 6h of onset indicated the core area of infarction (rCBF\<30% volume in CTP)\>1/2 MCA territory or ASPECTS score≤6 6.If endovascular-reperfusion therapy is performed, the treatment is not effective with one of the following conditions: A. The NIHSS score decreased≤4 and the total score was still\>15 B. The NIHSS score progressed immediately after the therapy and the total score≤30 7. Informed consent signed
Exclusion criteria
✕. Concurrent with one of the other cerebrovascular diseases of the following conditions:
✕. Hemorrhagic transformation in the infarct area, over 30% of the infarct area, and significant occupancy effect
✕. Severe hepatic or renal insufficiency (Note: severe hepatic insufficiency refers to the ALT\> 3 times the upper limit of normal or the AST \> 3 times the upper limit of normal; severe renal insufficiency means the creatinine value\> 1.5 times the upper limit of normal or GFR \<40 ml/min/1.73m2)