Induced Pluripotent Stem Cells-derived Small Extracellular Vesicles May Promote Neurological Function and Improve Cognitive Impairment in Acute Ischemic Stroke Patients

Обзор

This study primarily evaluates whether iEV nasal administration can improve neurological impairment and cognitive dysfunction in patients with acute cerebral infarction and cognitive impairment, and preliminarily explores its clinical efficacy.

Подробное описание

1. It is planned to enroll 40 patients with post - stroke cognitive impairment (PSCI, i.e., acute ischemic stroke (AIS) combined with cognitive impairment) who are hospitalized in the Department of Neurology and Stroke Ward of Shanghai Sixth People's Hospital. These patients should have had an AIS onset within 14 days. They will be divided into the PSCI + treatment group and the PSCI + control group according to a random number table, with 20 patients in each group. 2. Enrolled patients need to first complete blood tests such as blood routine and blood biochemistry, as well as skull MRI or skull CT examinations. The total course of treatment for both groups will be 12 weeks. 3. Both the treatment group and the control group will receive conventional basic treatment for cerebrovascular diseases. In addition, the treatment group will be given intranasal iEV administration, twice a week, 2 ml each time (with a concentration of 2×10¹⁰/ml), for 12 consecutive weeks. Before treatment and 12 weeks after treatment, the severity of neurological impairment, self - care ability, disability status, and cognitive function status will be evaluated to assess the therapeutic effect of iEV on neurological impairment and cognitive dysfunction in PSCI patients. 4. Before intranasal iEV treatment and 12 weeks after treatment, blood samples will be collected respectively to detect changes in indicators such as nerve cell damage, pro - inflammatory factors, angiogenesis, and blood - brain barrier disruption, so as to clarify the neuroprotective mechanism of iEV in PSCI patients.

Вмешательства

• Биопрепарат iEV
  Intranasal administration of iEV, twice a week, 2 ml each time (at a concentration of 2×10¹⁰/ml), for 12 consecutive weeks.
• Другое Basic treatments
  Basic treatments for cerebrovascular diseases such as antiplatelet aggregation, blood pressure control, blood glucose control, blood lipid control, and plaque stabilization.

Первичные конечные точки

• NIHSS [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• mRS [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• ADL [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• MoCA [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• MMSE [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Вторичные конечные точки (3)

• Indicators of pro-inflammatory factors [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Indicators of blood-brain barrier disruption [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Indicators of neuronal injury [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• Age ≥ 18 years old.
• Diagnosed with acute ischemic stroke (AIS) according to WHO criteria.
• Time from onset to enrollment ≤ 2 weeks (stable condition after admission and able to cooperate with cognitive assessment), accompanied by manifestations of cognitive impairment, with a score of < 26 on the Montreal Cognitive Assessment (MoCA) scale.
• Cerebral MRI or CT scan shows stroke lesions related to the condition.
• Subjects or their family members voluntarily participate and sign the informed consent form.

Критерии исключения

• A diagnosis of cognitive impairment prior to the onset of AIS;
• Presence of aphasia, hearing impairment, visual impairment, dysarthria, or other conditions that prevent completion of neuropsychological assessments;
• Patients with mental illnesses such as depression, anxiety disorder, or schizophrenia;
• Patients with severe diseases of the heart, liver, lungs, kidneys, or other vital organs;
• Patients with disturbed consciousness, a history of long-term alcohol consumption, a history of severe head trauma, or those who cannot cooperate with cognitive function tests for various reasons;
• illiterate patients.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Sixth People's Hospital — Шанхай

Идентификаторы

NCT: NCT07145294 · 2024-100-（1）

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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