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MSC Secretome and rTMS for Motor Recovery After Subacute Ischemic Stroke
Sponsor: Jumraini Tammasse
Summary
This randomized, double-blind, controlled clinical trial evaluates the effectiveness and safety of combined mesenchymal stem cell (MSC) secretome and repetitive transcranial magnetic stimulation (rTMS) for motor recovery in patients with subacute ischemic stroke. Participants will be randomized to either an intervention group receiving intravenous MSC secretome combined with high-frequency ipsilesional rTMS or a control group receiving placebo infusion and sham rTMS. The intervention is administered once weekly for 8 weeks. The primary outcome is change in motor function measured using the Fugl-Meyer Motor Scale. Secondary outcomes include changes in quantitative electroencephalography biomarkers, including sensorimotor rhythm, delta-theta-to-alpha-beta ratio, and beta coherence, as well as spasticity assessed using the Modified Ashworth Scale and treatment-related adverse events.
Official title: Effectiveness of Combined Mesenchymal Stem Cell Secretome and Repetitive Transcranial Magnetic Stimulation on Motor Recovery and Quantitative Electroencephalography Biomarkers in Patients With Subacute Ischemic Stroke: A Double-Blind Randomized Controlled Trial
Key Details
Gender
All
Age Range
30 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
205
Start Date
2026-11
Completion Date
2027-07
Last Updated
2026-10-14
Healthy Volunteers
No
Conditions
Interventions
Mesenchymal Stem Cell-Derived Secretome
Intravenous mesenchymal stem cell-derived secretome at a dose of 1.5 × 10\^9 particle equivalents is administered once weekly for 8 weeks. Administration is performed through intravenous access using aseptic technique by trained medical personnel, with monitoring for possible adverse events during and after administration.
Active Repetitive Transcranial Magnetic Stimulation
High-frequency repetitive transcranial magnetic stimulation is delivered at 10 Hz, 1500 pulses per session, at 80% of the resting motor threshold over the ipsilesional primary motor cortex (M1). Treatment is administered once weekly for 8 weeks.
0.9% Sodium Chloride Placebo
Participants in the control group receive an intravenous infusion of 0.9% sodium chloride as placebo according to the same treatment schedule as the active secretome intervention.
Sham Repetitive Transcranial Magnetic Stimulation
Sham repetitive transcranial magnetic stimulation is performed using procedures designed to resemble active rTMS without delivering therapeutic stimulation. Sham sessions follow the same treatment schedule as the active rTMS sessions.
Locations (1)
Inggit Medical Centre
Makassar, South Sulawesi, Indonesia