MSC Secretome Therapy for Cognitive Recovery After Subacute Ischemic Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorJumraini Tammasse
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Umbilical Cord Mesenchymal Stem Cell-Derived Secretome
- Standard Stroke Care and Rehabilitation
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jumraini Tammasse
Lead sponsor
Hasanuddin University
Sponsor institution
Source ClinicalTrials.gov