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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Umbilical Cord Mesenchymal Stem Cell-Derived Secretome
Biological/VaccineUmbilical 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.
Standard Stroke Care and Rehabilitation
Other interventionParticipants 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: MSC Secretome Plus Standard of CareExperimental treatment 2 interventions
Group B: Standard of Care AloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Montreal Cognitive Assessment-Indonesian Version Total Score
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.
Time frame
Baseline to week 8Secondary outcomes
1
Change in Delta-to-Alpha Ratio on Quantitative Electroencephalography
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.
Time frame
Baseline, week 4, and week 82
Change in Delta-Theta-to-Alpha-Beta Ratio on Quantitative Electroencephalography
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.
Time frame
Baseline, week 4, and week 83
Change in Relative Alpha Power on Quantitative Electroencephalography
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.
Time frame
Baseline, week 4, and week 84
Change in Relative Theta Power on Quantitative Electroencephalography
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.
Time frame
Baseline, week 4, and week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Jumraini Tammasse
Lead sponsor
Hasanuddin University
Sponsor institution
Source ClinicalTrials.gov