The Safety and Tolerability After Intravenous Infusion of UMC119-06 in Subjects With Acute Ischemic Stroke.
The clinical study with UMC119-06 is designed to investigate the safety in patients with acute ischemic stroke (AIS). This will be a dose escalation, open-label, single-center study in adult with acute ischemic stroke. UMC119-06 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for treatment of acute ischemic stroke.
• Subjects of age between ≥ 20 through ≤ 80 years.
• Subjects who had an onset of ischemic stroke within 48 to 168 hours before start of treatment.
• Subjects with occurrence of an ischemic stroke with clear motor or speech deficit documented by National Institutes of Health Stroke Scale (NIHSS) score of 5 to 20 (at the baseline assessment) that did not change by ≥4 points from the screening to the baseline assessment.
• Subjects who had an onset of ischemic stroke with large-artery atherosclerosis or cardioembolism.
• Subjects with confirmation of hemispheric cortical infarct with brain magnetic resonance imaging (MRI) including diffusion-weighted imaging demonstrating an acute lesion measuring \<100 mL.
• Subjects modified Rankin score of 0 or 1, reported by subject or family, prior to the onset of symptoms of the current stroke.
• Subjects with body weight of 50 to 90 kgs.
• Subject or legal guardian is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided, and has had the opportunity to discuss the study with the investigator or designee.
• Women of child-bearing potential should have a negative urine pregnancy test prior to administration of investigational product, UNLESS they meet the following criteria:
⁃ (1) Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels \> 40mIU/mL, OR; (2) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy