Clinical Trial of Umbilical Cord Mesenchymal Stem Cells in Subacute Ischemic Stroke

Официальное название

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of IxCell hUC-MSC-S in Patients With Ischemic Stroke in the Recovery Phase

Обзор

The goal of this clinical trial is to evaluate the efficacy, safety, and pharmacodynamic characteristics of Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSCs) in adults with ischemic stroke in the anterior circulation during the recovery phase. Researchers will compare hUC-MSCs to a placebo to determine whether hUC-MSCs treatment is effective in treating recovery-phase anterior circulation ischemic stroke.

Подробное описание

This study aims to further evaluate the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in the treatment of stroke. Eligible participants will be randomized to receive either intravenous infusions of hUC-MSCs or a matching placebo. Over the 12-month study period, participants will be required to attend regular clinic visits for comprehensive neurological assessments, including the Fugl-Meyer Assessment (FMA), Modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), Barthel Index (BI), and Mini-Mental State Examination (MMSE), as well as vascular imaging studies and biomarker analyses. Additionally, participants (or their caregivers, where applicable) will be instructed to consistently document neurological symptoms, functional activities, and the use of any rehabilitation medications or assistive devices.

Вмешательства

• Препарат Placebo
  Intravenous injection of placebo
• Препарат IxCell hUC-MSC-S (Human Umbilical Cord Mesenchymal Stem Cells)
  Intravenous injection of IxCell hUC-MSC-S

Первичные конечные точки

• Fugl-Meyer Assessment motor score [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Modified Rankin Scale [Срок оценки: 12 months]
• National Institutes of Health Stroke Scale [Срок оценки: 12 months]
• Barthel Index [Срок оценки: 12 months]
• Mini-Mental State Examination [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Age ≥18 years and ≤70 years, regardless of gender.
• 14 to 90 days after ischemic stroke.
• Clinical diagnosis of anterior circulation ischemic stroke.
• National Institutes of Health Stroke Scale (NIHSS) score is 6-20 points (inclusive), with NIHSS motor arm (item 5) or motor leg (item 6) score of 2-4 points, and NIHSS level of consciousness item (1a) score <2 points.
• It was anticipated that participants would either be able to give informed consent or have a legal representative who could do so.

Критерии исключения

• People who had a history of epilepsy, dementia, Parkinson's disease, severe depression, or other neurological or psychiatric disorders.
• Intracranial hemorrhagic conditions.
• Pre-stroke mRS score >1.
• Severe cardiovascular disease.
• Severe pulmonary diseases.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Xuanwu Hospital, Capital Medical University — Пекин

Идентификаторы

NCT: NCT07197606 · LC-MSC-IS25001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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