Ischemic StrokeNCT07874269
MSC Secretome and rTMS for Motor Recovery After Subacute Ischemic Stroke
A study testing Mesenchymal Stem Cell-Derived Secretome and Active Repetitive Transcranial Magnetic Stimulation in people with Ischemic Stroke, run by Jumraini Tammasse at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Mesenchymal Stem Cell-Derived Secretome and Active Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 to 75 years.
- Diagnosis of subacute ischemic stroke, 1 to 6 months after stroke onset.
- First-ever ischemic stroke.
- Ischemic stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT).
- Able to undergo repetitive transcranial magnetic stimulation (rTMS) therapy.
Who cannot join
- History of active seizures.
- Presence of intracranial metal or implanted devices that are contraindications to rTMS.
- Severe systemic disease that may affect participant safety or interfere with study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Inggit Medical Centre
Makassar, South Sulawesi, 90245
Jumraini Tammasse, Sp.N, Subsp.NRE(K), +6282188833368, Jumraini@med.unhas.ac.id
Novi Tejaya, MD, +6282126314018, tejayanovi@gmail.com
About this study
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
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.
Read the detailed description
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.
- Conditions
- Ischemic Stroke
- Being tested
- Mesenchymal Stem Cell-Derived Secretome, Active Repetitive Transcranial Magnetic Stimulation, 0.9% Sodium Chloride Placebo, Sham Repetitive Transcranial Magnetic Stimulation
- Keywords
- Subacute Ischemic Stroke, Motor Recovery, Mesenchymal Stem Cell Secretome, Repetitive Transcranial Magnetic Stimulation, rTMS, Quantitative Electroencephalography, qEEG, Fugl-Meyer Motor Scale, Neuroplasticity
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stem Cell-Derived SecretomeBiological
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 StimulationDevice
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 PlaceboDrug
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 StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| MSC Secretome Plus Active rTMS | Experimental | 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. Receives: Biological: Mesenchymal Stem Cell-Derived Secretome; Device: Active Repetitive Transcranial Magnetic Stimulation |
| Placebo Plus Sham rTMS | Placebo comparator | 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. Receives: Drug: 0.9% Sodium Chloride Placebo; Device: Sham Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to week 8
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Throughout the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to two parallel groups. The intervention group receives intravenous mesenchymal stem cell secretome combined with high-frequency repetitive transcranial magnetic stimulation, while the control group receives placebo infusion and sham repetitive transcranial magnetic stimulation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jumraini Tammasse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jumraini Tammasse, Hasanuddin University
- Investigators
- Jumraini Tammasse, Sp.N, Subsp.NRE(K), Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874269
- Sponsor's protocol ID
- UH26080847
- Other IDs
- 1117/UN4.6.4.5.31/PP36/2026
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07874269
- Acronym / sponsor ID
- UH26080847
- Conditions
- Ischemic Stroke
- Keywords
- Subacute Ischemic Stroke, Motor Recovery, Mesenchymal Stem Cell Secretome, Repetitive Transcranial Magnetic Stimulation, rTMS, Quantitative Electroencephalography, qEEG, Fugl-Meyer Motor Scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Jumraini TammasseUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to two parallel groups. The intervention group receives intravenous mesenchymal stem cell secretome combined with high-frequency repetitive transcranial magnetic stimulation, while the control group receives placebo infusion and sham repetitive transcranial magnetic stimulation.
| Arm | Type | Receives |
|---|---|---|
| MSC Secretome Plus Active rTMS | Experimental | Biological: Mesenchymal Stem Cell-Derived Secretome, Device: Active Repetitive Transcranial Magnetic StimulationParticipants 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. |
| Placebo Plus Sham rTMS | Placebo comparator | Drug: 0.9% Sodium Chloride Placebo, Device: Sham Repetitive Transcranial Magnetic StimulationParticipants 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30 to 75 years.
- Diagnosis of subacute ischemic stroke, 1 to 6 months after stroke onset.
- First-ever ischemic stroke.
- Ischemic stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT).
- Able to undergo repetitive transcranial magnetic stimulation (rTMS) therapy.
Key exclusion criteria (3 listed)
- History of active seizures.
- Presence of intracranial metal or implanted devices that are contraindications to rTMS.
- Severe systemic disease that may affect participant safety or interfere with study participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal Stem Cell-Derived SecretomeIntravenous 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. | Biological | MSC Secretome Plus Active rTMS |
| Active Repetitive Transcranial Magnetic StimulationHigh-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. | Device | MSC Secretome Plus Active rTMS |
| 0.9% Sodium Chloride PlaceboParticipants 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. | Drug | Placebo Plus Sham rTMS |
| Sham Repetitive Transcranial Magnetic StimulationSham 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. | Device | Placebo Plus Sham rTMS |
Primary outcome
Change in Fugl-Meyer Motor Scale Score
Time frame: Baseline to week 8
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.
5 secondary outcomes
Change in Sensorimotor Rhythm on Quantitative Electroencephalography
Time frame: Baseline to week 8
Change in Delta-Theta-to-Alpha-Beta Ratio on Quantitative Electroencephalography
Time frame: Baseline to week 8
Change in Beta-Band Coherence on Quantitative Electroencephalography
Time frame: Baseline to week 8
Change in Modified Ashworth Scale Score
Time frame: Baseline to week 8
Incidence of Adverse Events
Time frame: Throughout the 8-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jumraini Tammasse, Sp.N, Subsp.NRE(K) principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesenchymal Stem Cell-Derived Secretome and Active Repetitive Transcranial Magnetic Stimulation in people with Ischemic Stroke, run by Jumraini Tammasse at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jumraini Tammasse, Sp.N(K), Subsp.NRE(K) (+6282188833368, Jumraini@med.unhas.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer Motor Scale Score (time frame: Baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.