MSC Secretome Therapy for Cognitive Recovery After Subacute Ischemic Stroke
2026년 7월 23일 업데이트: Jumraini Tammasse
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
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.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
70
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Jumraini Tammasse, Sp.N, Subsp.NRE(K)
- 전화번호: +6282188833368
- 이메일: tejayanovi@gmail.com
연구 장소
-
-
South Sulawesi
-
Makassar, South Sulawesi, 인도네시아, 90245
- 모병
- Hasanuddin University Hospital
-
연락하다:
- Jumraini Tammasse, Sp.N, Subsp.NRE(K)
- 전화번호: +6282188833368
- 이메일: tejayanovi@gmail.com
-
연락하다:
- Novi Tejaya, MD
- 전화번호: +6282126314018
- 이메일: tejayanovi@gmail.com
-
수석 연구원:
- Jumraini Tammasse, Sp.N, Subsp.NRE(K)
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: MSC Secretome Plus Standard of Care
Participants receive standard medical treatment and standardized stroke rehabilitation plus umbilical cord mesenchymal stem cell-derived secretome.
The secretome intervention is administered according to the study protocol, with safety monitoring during and after administration.
|
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.
다른 이름들:
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.
|
|
활성 비교기: Standard of Care Alone
Participants receive standard medical treatment and standardized stroke rehabilitation without MSC secretome.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Montreal Cognitive Assessment-Indonesian Version Total Score
기간: 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.
|
Baseline to week 8
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Delta-to-Alpha Ratio on Quantitative Electroencephalography
기간: Baseline, week 4, and week 8
|
The delta-to-alpha ratio is calculated from quantitative electroencephalography spectral power measurements.
The outcome is the change in DAR from baseline to week 4 and week 8.
|
Baseline, week 4, and week 8
|
|
Change in Delta-Theta-to-Alpha-Beta Ratio on Quantitative Electroencephalography
기간: Baseline, week 4, and week 8
|
The delta-theta-to-alpha-beta ratio is calculated from quantitative electroencephalography spectral power measurements.
The outcome is the change in DTABR from baseline to week 4 and week 8.
|
Baseline, week 4, and week 8
|
|
Change in Relative Alpha Power on Quantitative Electroencephalography
기간: Baseline, week 4, and week 8
|
Relative alpha power is derived from quantitative electroencephalography spectral power analysis.
The outcome is the change in relative alpha power from baseline to week 4 and week 8.
|
Baseline, week 4, and week 8
|
|
Change in Relative Theta Power on Quantitative Electroencephalography
기간: Baseline, week 4, and week 8
|
Relative theta power is derived from quantitative electroencephalography spectral power analysis.
The outcome is the change in relative theta power from baseline to week 4 and week 8.
|
Baseline, week 4, and week 8
|
|
Change in Serum Brain-Derived Neurotrophic Factor Concentration
기간: Baseline and week 8
|
Serum brain-derived neurotrophic factor concentration is measured using an enzyme-linked immunosorbent assay.
The outcome is the change in serum BDNF concentration from baseline to week 8.
|
Baseline and week 8
|
|
Change in Serum Interleukin-1 Beta Concentration
기간: Baseline and week 8
|
Serum interleukin-1 beta concentration is measured using an enzyme-linked immunosorbent assay.
The outcome is the change in serum IL-1 beta concentration from baseline to week 8.
|
Baseline and week 8
|
|
Change in National Institutes of Health Stroke Scale Score
기간: Baseline, week 4, and week 8
|
The National Institutes of Health Stroke Scale assesses neurological impairment.
Scores range from 0 to 42, with higher scores indicating greater neurological impairment.
The outcome is the change in NIHSS score from baseline to week 4 and week 8.
|
Baseline, week 4, and week 8
|
|
Change in Modified Rankin Scale Score
기간: Baseline, week 4, and week 8
|
The modified Rankin Scale assesses global disability after stroke.
Scores range from 0 to 6, with higher scores indicating greater disability or death.
The outcome is the change in modified Rankin Scale score from baseline to week 4 and week 8.
|
Baseline, week 4, and week 8
|
|
Incidence of Treatment-Emergent Adverse Events
기간: From the first intervention through week 8
|
The number and proportion of participants experiencing adverse events, including hypersensitivity reactions, fever, administration-related reactions, hospitalization, seizure, infection, neurological deterioration, and death, will be recorded.
|
From the first intervention through week 8
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Jumraini Tammasse, Sp.N, Subsp.NRE(K), Hasanuddin University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
연구 시작
2026년 7월 9일
기본 완료 (추정된)
기본 완료
2026년 11월 1일
연구 완료 (추정된)
연구 완료
2026년 12월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 23일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 23일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 28일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 28일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 23일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- UH26060713
- 847/UN4.6.4.5.31/PP36/2026 (기타 식별자: Health Research Ethics Committee, Faculty of Medicine, Hasanuddin University)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data sharing is not currently planned.
Participant data will be coded, stored securely, and reported only in aggregate form without direct personal identifiers.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .