MSC Secretome Therapy for Cognitive Recovery After Subacute Ischemic Stroke
Official title: 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
Run by Hasanuddin University · NCT07731087 · Data updated 2026-11-12
This pilot trial tests whether adding mesenchymal stem cell secretome to standard stroke care helps improve cognitive recovery in adults 40–75 with subacute ischemic stroke and mild-to-moderate cognitive impairment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 75 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | Hasanuddin University Academic / other |
| Locations | 1 site (Makassar, South Sulawesi) |
| Status | Recruiting |
| Started | July 9, 2026 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | July 28, 2026 |
| Trial ID | NCT07731087 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are 40–75 years old with ischemic stroke 7 days to 3 months prior and mild-to-moderate cognitive impairment confirmed by MoCA-Ina, who are hemodynamically stable and able to complete cognitive assessments.
✕Probably not a fit
Patients with hemorrhagic stroke, severe cognitive impairment prohibiting assessment, major comorbidities, or contraindications to the study intervention may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a small, parallel-group randomized trial with blinded outcome assessment. Participants with ischemic stroke 7 days to 3 months prior and mild-to-moderate cognitive impairment will receive standard care and rehabilitation, with or without MSC-derived secretome. Primary outcome is change in MoCA-Ina score at 8 weeks; secondary outcomes include EEG measures, biomarkers, neurological and functional scales, and safety data. The study uses block randomization and allocation concealment, with outcome assessors blinded to treatment. Baseline and follow-up assessments cover demographics, vascular risk, cognition, function, electrophysiology, and biomarkers.
Why it matters
Potential benefit: If successful, the secretome add-on could improve cognitive recovery and functional independence after subacute ischemic stroke.
How similar studies have gone: Previous related work in stem cell-derived secretomes for neurological recovery shows potential, but this approach remains exploratory in ischemic stroke.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Hasanuddin University Hospital
Makassar, South Sulawesi, Indonesia Recruiting
Study contacts
- Principal investigator: Jumraini Tammasse, Sp.N, Subsp.NRE(K) — Hasanuddin University
- Study coordinator: Jumraini Tammasse, Sp.N, Subsp.NRE(K)
- Email: tejayanovi@gmail.com
- Phone: +6282188833368
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.