An interventional study of Mesenchymal Stem Cell-Derived Secretome and Active Repetitive Transcranial Magnetic Stimulation in Ischemic Stroke, sponsored by Jumraini Tammasse. Not yet recruiting at 1 site in Indonesia. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Jumraini Tammasse · Not applicable, Interventional, and Treatment
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.
This study is a double-blind, randomized controlled clinical trial designed to evaluate the effectiveness and safety of combined intravenous mesenchymal stem cell (MSC) secretome and high-frequency repetitive transcranial magnetic stimulation (rTMS) in patients with subacute ischemic stroke.
A total of 205 participants are planned to be enrolled. Eligible participants are patients aged 30 to 75 years with a first ischemic stroke confirmed by computed tomography or magnetic resonance imaging and who are able to undergo rTMS therapy. Participants will be randomized into an intervention group and a control group.
The intervention group will receive intravenous MSC secretome at a dose of 1.5 × 10\^9 particle equivalents once weekly for 8 weeks, combined with high-frequency rTMS at 10 Hz, 1500 pulses per session, and an intensity of 80% of the resting motor threshold applied to the ipsilesional primary motor cortex (M1). The control group will receive a 0.9% sodium chloride placebo infusion and sham rTMS using procedures designed to resemble the active intervention.
Motor function will be assessed using the Fugl-Meyer Motor Scale before and after the intervention. Quantitative electroencephalography will be used to evaluate neurophysiological biomarkers of neuroplasticity, including sensorimotor rhythm, delta-theta-to-alpha-beta ratio, and beta coherence. Spasticity will be assessed using the Modified Ashworth Scale. Safety will be evaluated by systematic monitoring and recording of adverse events throughout the intervention period.
The primary objective is to compare the change in Fugl-Meyer Motor Scale scores between the intervention and control groups. Secondary objectives are to evaluate changes in quantitative electroencephalography parameters, assess treatment-related adverse events, and examine the relationship between clinical motor improvement and changes in neurophysiological biomarkers.
2,653 studies on the registry are indexed under Ischemic Stroke; 936 are open to participants now.
This study's planned enrollment of 205 is above the median of 120 across 1,799 interventional studies indexed under Ischemic Stroke.
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Exclusion Criteria:
Participants receive intravenous mesenchymal stem cell secretome combined with active high-frequency repetitive transcranial magnetic stimulation. MSC secretome is administered once weekly for 8 weeks. Active rTMS is delivered at 10 Hz, 1500 pulses per session, at 80% of the resting motor threshold over the ipsilesional primary motor cortex.
Biological: Mesenchymal Stem Cell-Derived Secretome · Device: Active Repetitive Transcranial Magnetic Stimulation
Participants receive placebo infusion with 0.9% sodium chloride combined with sham repetitive transcranial magnetic stimulation. The placebo and sham procedures are designed to resemble the active interventions and are administered according to the same study schedule.
Drug: 0.9% Sodium Chloride Placebo · Device: Sham Repetitive Transcranial Magnetic Stimulation
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.
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.
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 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.
Change in Fugl-Meyer Motor Scale Score
Motor function is assessed using the Fugl-Meyer Motor Scale. The motor score ranges from 0 to 100, with higher scores indicating better motor function and lower scores indicating greater motor impairment. The outcome is the change in total Fugl-Meyer Motor Scale score from baseline to the end of the 8-week intervention period.
Time frame: Baseline to week 8
Change in Sensorimotor Rhythm on Quantitative Electroencephalography
Sensorimotor rhythm is assessed using quantitative electroencephalography as a neurophysiological marker of neuroplasticity. The outcome is the change in sensorimotor rhythm from baseline to the end of the 8-week intervention period.
Time frame: Baseline to week 8
Change in Delta-Theta-to-Alpha-Beta Ratio on Quantitative Electroencephalography
The delta-theta-to-alpha-beta ratio is derived from quantitative electroencephalography spectral analysis. The outcome is the change in delta-theta-to-alpha-beta ratio from baseline to the end of the 8-week intervention period.
Time frame: Baseline to week 8
Change in Beta-Band Coherence on Quantitative Electroencephalography
Beta-band coherence is assessed using quantitative electroencephalography as a measure of functional connectivity. The outcome is the change in beta-band coherence from baseline to the end of the 8-week intervention period.
Time frame: Baseline to week 8
Change in Modified Ashworth Scale Score
Spasticity is assessed using the Modified Ashworth Scale, which ranges from 0 to 4, with an additional grade of 1+. Higher scores indicate greater muscle tone and more severe spasticity, while lower scores indicate less spasticity. The outcome is the change in Modified Ashworth Scale score from baseline to the end of the 8-week intervention period.
Time frame: Baseline to week 8
Incidence of Adverse Events
The incidence and type of adverse events occurring during the intervention period will be recorded to evaluate treatment safety.
Time frame: Throughout the 8-week intervention period
Plan to share: No — Individual participant data will not be shared because the study protocol and informed consent do not include a plan for public or external sharing of de-identified participant-level data.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Jumraini Tammasse