A phase I/IIa clinical trial investigating the safety and preliminary efficacy of intravenous administration of human induced neural stem cell-derived exosomes for acute ischemic stroke
Aged 18-80 years (inclusive), regardless of gender;
Clinically diagnosed with an anterior circulation ischemic stroke in the current episode, confirmed by head MRI/CT, and able to receive the investigational product within 1 week after symptom onset;
National Institutes of Health Stroke Scale (NIHSS) score of 6-20 (inclusive) at randomization, with NIHSS item Ia score <2, and a change in NIHSS score from baseline to randomization of <4 points;
Female subjects of childbearing potential, or male subjects with partners of childbearing potential, must have no plans for pregnancy during the study and voluntarily use effective contraception;
Those with epilepsy, Alzheimer's disease, Parkinson's disease, severe depression, or other neurological disorders or psychiatric illnesses that the investigator deems would impair their ability to participate in the trial or affect the assessment of the study;
Patients who have experienced hemorrhagic transformation after the current ischemic stroke and are deemed unsuitable for participation in the clinical trial by the investigator;
Patients with malignant tumors, except for those with low-grade malignant tumors such as basal cell carcinoma, papillary thyroid carcinoma, and localized prostate cancer in situ, who have received radical treatment for more than five years;
Patients with severe infections, including sepsis, septic shock, severe pneumonia (refer to the 2007 criteria for severe pneumonia in adults by the Infectious Diseases Society of America/American Thoracic Society for the diagnosis of severe pneumonia);
Parallel
iNSC-EV01
DrugIntravenous induced neural stem cell-derived exosome
Placebo
DrugiNSC-EV01 mimics
Dose limiting toxicity
mRS
modified Ranking Scale (mRS), ranging from 0 to 6, with higher scores indicating worse outcome, and a score of 6 representing death.
AEs and SAEs
Adverse events and severe adverse events
mRS
modified Ranking Scale (mRS), which ranges from 0 to 6, with higher scores indicating worse outcome, and a score of 6 representing death.
Percentage of mRS 0-2
modified Ranking Scale (mRS), which ranges from 0 to 6, with higher scores indicating worse outcome, and a score of 6 representing death.
NIHSS score change compared to baseline
National Institutes of Health Stroke Scale (NIHSS), ranging from 0 to42, with higher score indicating more severe disabilities
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Xuanwu Hospital, Beijing
Lead sponsor
Wiseheart Co.Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
