MSC Secretome Therapy for Cognitive Recovery After Subacute Ischemic Stroke

Официальное название

Efficacy of Mesenchymal Stem Cell Secretome Therapy on Cognitive Recovery in Patients With Subacute Ischemic Stroke: A Pilot Randomized Controlled Trial Using qEEG, BDNF, and Interleukin-1β Evaluation

Обзор

Post-stroke cognitive impairment can limit rehabilitation, independence, and quality of life after ischemic stroke. This pilot randomized controlled trial evaluates whether mesenchymal stem cell-derived secretome, given in addition to standard stroke care and rehabilitation, improves cognitive recovery in patients with subacute ischemic stroke. Participants aged 40 to 75 years with ischemic stroke occurring 7 days to 3 months previously and mild-to-moderate cognitive impairment will be randomly assigned in a 1:1 ratio to receive standard care and rehabilitation plus MSC secretome or standard care and rehabilitation without MSC secretome. The primary outcome is the change in the Indonesian version of the Montreal Cognitive Assessment score. Secondary outcomes include quantitative electroencephalography parameters, serum brain-derived neurotrophic factor, serum interleukin-1β, NIHSS, modified Rankin Scale, and adverse events.

Подробное описание

This study is a pilot, parallel-group, randomized controlled trial with blinded outcome assessment. The study population consists of patients aged 40 to 75 years with clinically and radiologically confirmed subacute ischemic stroke, defined as 7 days to 3 months after stroke onset. Eligible participants must be hemodynamically stable, able to undergo a basic neuropsychological assessment, and have mild-to-moderate cognitive impairment based on the Indonesian version of the Montreal Cognitive Assessment.

Participants will be randomized in a 1:1 ratio using block randomization with allocation concealment. The intervention group will receive standard stroke care and rehabilitation plus umbilical cord mesenchymal stem cell-derived secretome. The control group will receive standard medical treatment and standardized stroke rehabilitation without MSC secretome. Outcome assessors will remain unaware of treatment allocation.

Baseline assessments include demographic and vascular risk factor data, NIHSS, modified Rankin Scale, MoCA-Ina, quantitative electroencephalography, serum brain-derived neurotrophic factor, and serum interleukin-1β. Follow-up assessments will include cognitive, neurological, functional, electrophysiological, biomarker, and safety evaluations at the prespecified study visits.

The primary outcome is the change in MoCA-Ina total score from baseline to week 8. Secondary outcomes include changes in delta-to-alpha ratio, delta-theta-to-alpha-beta ratio, relative alpha power, relative theta power, serum BDNF, serum IL-1β, NIHSS, modified Rankin Scale, and the incidence of adverse events. The primary analysis will follow the intention-to-treat principle, with per-protocol analysis as an additional analysis.

Вмешательства

• Биопрепарат Umbilical Cord Mesenchymal Stem Cell-Derived Secretome
  Umbilical cord mesenchymal stem cell-derived secretome is administered in addition to standard medical treatment and standardized stroke rehabilitation. The intervention is administered twice, on day 1 and day 8, according to the investigational product protocol. Participants are monitored during and after administration for hypersensitivity reactions, fever, and other adverse events.
• Другое Standard Stroke Care and Rehabilitation
  Participants receive standard medical management for subacute ischemic stroke and standardized stroke rehabilitation according to the treating physician and institutional clinical practice. The same standard care and rehabilitation are provided to both study groups.

Первичные конечные точки

• Change in Montreal Cognitive Assessment-Indonesian Version Total Score [Срок оценки: Baseline to week 8]

Вторичные конечные точки (9)

• Change in Delta-to-Alpha Ratio on Quantitative Electroencephalography [Срок оценки: Baseline, week 4, and week 8]
• Change in Delta-Theta-to-Alpha-Beta Ratio on Quantitative Electroencephalography [Срок оценки: Baseline, week 4, and week 8]
• Change in Relative Alpha Power on Quantitative Electroencephalography [Срок оценки: Baseline, week 4, and week 8]
• Change in Relative Theta Power on Quantitative Electroencephalography [Срок оценки: Baseline, week 4, and week 8]
• Change in Serum Brain-Derived Neurotrophic Factor Concentration [Срок оценки: Baseline and week 8]
• Change in Serum Interleukin-1 Beta Concentration [Срок оценки: Baseline and week 8]
• Change in National Institutes of Health Stroke Scale Score [Срок оценки: Baseline, week 4, and week 8]
• Change in Modified Rankin Scale Score [Срок оценки: Baseline, week 4, and week 8]
• Incidence of Treatment-Emergent Adverse Events [Срок оценки: From the first intervention through week 8]

Критерии участия

Критерии включения

• Age 40 to 75 years.
• Diagnosis of ischemic stroke confirmed by clinical examination and computed tomography or magnetic resonance imaging.
• Stroke onset between 7 days and 3 months before enrollment.
• Hemodynamically stable.
• Able to undergo a basic neuropsychological assessment.
• Mild-to-moderate cognitive impairment based on the Indonesian version of the Montreal Cognitive Assessment.
• Willing to participate in the study and provide written informed consent.

Критерии исключения

• Hemorrhagic stroke or mixed ischemic and hemorrhagic stroke.
• Severe aphasia, impaired consciousness, or severe sensory deficits that make cognitive assessment invalid.
• History of dementia before stroke or a major neurodegenerative disorder.
• Active infection, active autoimmune disease, active malignancy, severe renal failure, or severe liver failure.
• Uncontrolled epilepsy.
• Concurrent participation in another clinical trial.
• Contraindication to any study intervention or study procedure.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Hasanuddin University Hospital — Makassar

Идентификаторы

NCT: NCT07731087 · UH26060713 · 847/UN4.6.4.5.31/PP36/2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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