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MSC Secretome Therapy for Cognitive Recovery After Subacute Ischemic Stroke

23 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

70

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Jumraini Tammasse, Sp.N, Subsp.NRE(K)
  • Telefoonnummer: +6282188833368
  • E-mail: tejayanovi@gmail.com

Studie Locaties

  • Indonesië
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesië, 90245
        • Werving
        • Hasanuddin University Hospital
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Jumraini Tammasse, Sp.N, Subsp.NRE(K)

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Biologisch: 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.
Andere namen:
  • USEPro
Ander: 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.
Actieve vergelijker: Standard of Care Alone
Participants receive standard medical treatment and standardized stroke rehabilitation without MSC secretome.
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Montreal Cognitive Assessment-Indonesian Version Total Score
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Delta-to-Alpha Ratio on Quantitative Electroencephalography
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Jumraini Tammasse

Onderzoekers

  • Hoofdonderzoeker: Jumraini Tammasse, Sp.N, Subsp.NRE(K), Hasanuddin University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 juli 2026

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

23 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 juli 2026

Eerst geplaatst (Werkelijk)

28 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

23 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UH26060713
  • 847/UN4.6.4.5.31/PP36/2026 (Andere identificatie: Health Research Ethics Committee, Faculty of Medicine, Hasanuddin University)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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