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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in Montreal Cognitive Assessment-Indonesian Version Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors responsible for the MoCA-Ina, NIHSS, modified Rankin Scale, and quantitative electroencephalography assessments are blinded to treatment allocation. The randomization sequence and treatment assignment are not disclosed to the outcome assessors
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Montreal Cognitive Assessment-Indonesian Version Total Score
时间窗: Baseline to week 8
The MoCA-Ina assesses visuospatial-executive function, naming, attention, language, abstraction, delayed recall, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. The outcome is the change in total MoCA-Ina score from baseline to the final follow-up assessment.
次要结局
- Change in Delta-to-Alpha Ratio on Quantitative Electroencephalography(Baseline, week 4, and week 8)
- Change in Delta-Theta-to-Alpha-Beta Ratio on Quantitative Electroencephalography(Baseline, week 4, and week 8)
- Change in Relative Alpha Power on Quantitative Electroencephalography(Baseline, week 4, and week 8)
- Change in Relative Theta Power on Quantitative Electroencephalography(Baseline, week 4, and week 8)
- Change in Serum Brain-Derived Neurotrophic Factor Concentration(Baseline and week 8)
- Change in Serum Interleukin-1 Beta Concentration(Baseline and week 8)
- Change in National Institutes of Health Stroke Scale Score(Baseline, week 4, and week 8)
- Change in Modified Rankin Scale Score(Baseline, week 4, and week 8)
- Incidence of Treatment-Emergent Adverse Events(From the first intervention through week 8)
研究者
Jumraini Tammasse
Principal Investigator
Hasanuddin University