Ischemic StrokeNCT07731087
MSC Secretome Therapy for Cognitive Recovery After Subacute Ischemic Stroke
A study testing Umbilical Cord Mesenchymal Stem Cell-Derived Secretome and Standard Stroke Care and Rehabilitation in people with Ischemic Stroke and Post-Stroke Cognitive Impairment, run by Jumraini Tammasse at 1 site in Indonesia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Ischemic Stroke, Post-Stroke Cognitive Impairment
- What is being tested?
- Umbilical Cord Mesenchymal Stem Cell-Derived Secretome and Standard Stroke Care and Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 9 Jul 2026to Dec 2026
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Able to undergo a basic neuropsychological assessment.
- Mild-to-moderate cognitive impairment based on the Indonesian version of the Montreal Cognitive Assessment.
- Willing to participate in the study and provide written informed consent.
Who cannot join
- 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.
- Uncontrolled epilepsy.
- Concurrent participation in another clinical trial.
- Contraindication to any study intervention or study procedure.
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, 1 recruiting
- Recruiting
Hasanuddin University Hospital
Makassar, South Sulawesi, 90245
Jumraini Tammasse, Sp.N, Subsp.NRE(K), +6282188833368, tejayanovi@gmail.com
Novi Tejaya, MD, +6282126314018, tejayanovi@gmail.com
About this study
Official title: Efficacy of Mesenchymal Stem Cell Secretome Therapy on Cognitive Recovery in Patients With Subacute Ischemic Stroke: A Pilot Randomized Controlled Trial Using qEEG, BDNF, and Interleukin-1β Evaluation
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.
Read the detailed description
This study is a pilot, parallel-group, randomized controlled trial with blinded outcome assessment. The study population consists of patients aged 40 to 75 years with clinically and radiologically confirmed subacute ischemic stroke, defined as 7 days to 3 months after stroke onset. Eligible participants must be hemodynamically stable, able to undergo a basic neuropsychological assessment, and have mild-to-moderate cognitive impairment based on the Indonesian version of the Montreal Cognitive Assessment.
Participants will be randomized in a 1:1 ratio using block randomization with allocation concealment. The intervention group will receive standard stroke care and rehabilitation plus umbilical cord mesenchymal stem cell-derived secretome. The control group will receive standard medical treatment and standardized stroke rehabilitation without MSC secretome. Outcome assessors will remain unaware of treatment allocation.
Baseline assessments include demographic and vascular risk factor data, NIHSS, modified Rankin Scale, MoCA-Ina, quantitative electroencephalography, serum brain-derived neurotrophic factor, and serum interleukin-1β. Follow-up assessments will include cognitive, neurological, functional, electrophysiological, biomarker, and safety evaluations at the prespecified study visits.
The primary outcome is the change in MoCA-Ina total score from baseline to week 8. Secondary outcomes include changes in delta-to-alpha ratio, delta-theta-to-alpha-beta ratio, relative alpha power, relative theta power, serum BDNF, serum IL-1β, NIHSS, modified Rankin Scale, and the incidence of adverse events. The primary analysis will follow the intention-to-treat principle, with per-protocol analysis as an additional analysis.
- Conditions
- Ischemic Stroke, Post-Stroke Cognitive Impairment
- Being tested
- Umbilical Cord Mesenchymal Stem Cell-Derived Secretome, Standard Stroke Care and Rehabilitation
- Keywords
- Subacute ischemic stroke, Post-stroke cognitive impairment, Mesenchymal stem cell secretome, MSC secretome, Cognitive recovery, MoCA-Ina, Quantitative electroencephalography, qEEG, Brain-derived neurotrophic factor, BDNF, Interleukin-1 beta, IL-1β
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord Mesenchymal Stem Cell-Derived SecretomeBiological
Also called USEPro
Umbilical 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 RehabilitationOther
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| MSC Secretome Plus Standard of Care | Experimental | Participants receive standard medical treatment and standardized stroke rehabilitation plus umbilical cord mesenchymal stem cell-derived secretome. The secretome intervention is administered according to the study protocol, with safety monitoring during and after administration. Receives: Biological: Umbilical Cord Mesenchymal Stem Cell-Derived Secretome; Other: Standard Stroke Care and Rehabilitation |
| Standard of Care Alone | Active comparator | Participants receive standard medical treatment and standardized stroke rehabilitation without MSC secretome. Receives: Other: Standard Stroke Care and Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to week 8
Secondary outcomes (9)
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.
Measured: Baseline, week 4, and week 8
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.
Measured: Baseline, week 4, and week 8
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.
Measured: Baseline, week 4, and week 8
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.
Measured: Baseline, week 4, and week 8
Change in Serum Brain-Derived Neurotrophic Factor Concentration
Serum brain-derived neurotrophic factor concentration is measured using an enzyme-linked immunosorbent assay. The outcome is the change in serum BDNF concentration from baseline to week 8.
Measured: Baseline and week 8
Change in Serum Interleukin-1 Beta Concentration
Serum interleukin-1 beta concentration is measured using an enzyme-linked immunosorbent assay. The outcome is the change in serum IL-1 beta concentration from baseline to week 8.
Measured: Baseline and week 8
Change in National Institutes of Health Stroke Scale Score
The National Institutes of Health Stroke Scale assesses neurological impairment. Scores range from 0 to 42, with higher scores indicating greater neurological impairment. The outcome is the change in NIHSS score from baseline to week 4 and week 8.
Measured: Baseline, week 4, and week 8
Change in Modified Rankin Scale Score
The modified Rankin Scale assesses global disability after stroke. Scores range from 0 to 6, with higher scores indicating greater disability or death. The outcome is the change in modified Rankin Scale score from baseline to week 4 and week 8.
Measured: Baseline, week 4, and week 8
Incidence of Treatment-Emergent Adverse Events
The number and proportion of participants experiencing adverse events, including hypersensitivity reactions, fever, administration-related reactions, hospitalization, seizure, infection, neurological deterioration, and death, will be recorded.
Measured: From the first intervention through week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start9 Jul 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (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 in a 1:1 ratio to two parallel groups. The experimental group receives umbilical cord mesenchymal stem cell-derived secretome in addition to standard stroke care and rehabilitation. The control group receives standard stroke care and rehabilitation without MSC secretome.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 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
- NCT07731087
- Sponsor's protocol ID
- UH26060713
- Other IDs
- 847/UN4.6.4.5.31/PP36/2026
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data sharing is not currently planned. Participant data will be coded, stored securely, and reported only in aggregate form without direct personal identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mesenchymal Stem Cell Secretome Therapy on Cognitive Recovery in Patients With Subacute Ischemic Stroke: A Pilot Randomized Controlled Trial Using qEEG, BDNF, and Interleukin-1β Evaluation
- ClinicalTrials.gov ID
- NCT07731087
- Acronym / sponsor ID
- UH26060713
- Conditions
- Ischemic Stroke, Post-Stroke Cognitive Impairment
- Keywords
- Subacute ischemic stroke, Post-stroke cognitive impairment, Mesenchymal stem cell secretome, MSC secretome, Cognitive recovery, MoCA-Ina, Quantitative electroencephalography, qEEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Jumraini TammasseUniversity, hospital or other
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Jul 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.
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.
Detailed description
This study is a pilot, parallel-group, randomized controlled trial with blinded outcome assessment. The study population consists of patients aged 40 to 75 years with clinically and radiologically confirmed subacute ischemic stroke, defined as 7 days to 3 months after stroke onset. Eligible participants must be hemodynamically stable, able to undergo a basic neuropsychological assessment, and have mild-to-moderate cognitive impairment based on the Indonesian version of the Montreal Cognitive Assessment.
Participants will be randomized in a 1:1 ratio using block randomization with allocation concealment. The intervention group will receive standard stroke care and rehabilitation plus umbilical cord mesenchymal stem cell-derived secretome. The control group will receive standard medical treatment and standardized stroke rehabilitation without MSC secretome. Outcome assessors will remain unaware of treatment allocation.
Baseline assessments include demographic and vascular risk factor data, NIHSS, modified Rankin Scale, MoCA-Ina, quantitative electroencephalography, serum brain-derived neurotrophic factor, and serum interleukin-1β. Follow-up assessments will include cognitive, neurological, functional, electrophysiological, biomarker, and safety evaluations at the prespecified study visits.
The primary outcome is the change in MoCA-Ina total score from baseline to week 8. Secondary outcomes include changes in delta-to-alpha ratio, delta-theta-to-alpha-beta ratio, relative alpha power, relative theta power, serum BDNF, serum IL-1β, NIHSS, modified Rankin Scale, and the incidence of adverse events. The primary analysis will follow the intention-to-treat principle, with per-protocol analysis as an additional analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned in a 1:1 ratio to two parallel groups. The experimental group receives umbilical cord mesenchymal stem cell-derived secretome in addition to standard stroke care and rehabilitation. The control group receives standard stroke care and rehabilitation without MSC secretome.
| Arm | Type | Receives |
|---|---|---|
| MSC Secretome Plus Standard of Care | Experimental | Biological: Umbilical Cord Mesenchymal Stem Cell-Derived Secretome, Other: Standard Stroke Care and RehabilitationParticipants receive standard medical treatment and standardized stroke rehabilitation plus umbilical cord mesenchymal stem cell-derived secretome. The secretome intervention is administered according to the study protocol, with safety monitoring during and after administration. |
| Standard of Care Alone | Active comparator | Other: Standard Stroke Care and RehabilitationParticipants receive standard medical treatment and standardized stroke rehabilitation without MSC secretome. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Able to undergo a basic neuropsychological assessment.
Key exclusion criteria (7 listed)
- 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.
- Uncontrolled epilepsy.
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 |
|---|---|---|
| Umbilical Cord Mesenchymal Stem Cell-Derived SecretomeAlso: USEProUmbilical 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. | Biological | MSC Secretome Plus Standard of Care |
| Standard Stroke Care and RehabilitationParticipants 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. | Other | MSC Secretome Plus Standard of Care, Standard of Care Alone |
Primary outcome
Change in Montreal Cognitive Assessment-Indonesian Version Total Score
Time frame: Baseline to week 8
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.
9 secondary outcomes
Change in Delta-to-Alpha Ratio on Quantitative Electroencephalography
Time frame: Baseline, week 4, and week 8
Change in Delta-Theta-to-Alpha-Beta Ratio on Quantitative Electroencephalography
Time frame: Baseline, week 4, and week 8
Change in Relative Alpha Power on Quantitative Electroencephalography
Time frame: Baseline, week 4, and week 8
Change in Relative Theta Power on Quantitative Electroencephalography
Time frame: Baseline, week 4, and week 8
Change in Serum Brain-Derived Neurotrophic Factor Concentration
Time frame: Baseline and week 8
Change in Serum Interleukin-1 Beta Concentration
Time frame: Baseline and week 8
Change in National Institutes of Health Stroke Scale Score
Time frame: Baseline, week 4, and week 8
Change in Modified Rankin Scale Score
Time frame: Baseline, week 4, and week 8
Incidence of Treatment-Emergent Adverse Events
Time frame: From the first intervention through week 8
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 28 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data sharing is not currently planned. Participant data will be coded, stored securely, and reported only in aggregate form without direct personal identifiers.
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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 Umbilical Cord Mesenchymal Stem Cell-Derived Secretome and Standard Stroke Care and Rehabilitation in people with Ischemic Stroke and Post-Stroke Cognitive Impairment, 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 28 Jul 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. 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, Subsp.NRE(K) (+6282188833368, tejayanovi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment-Indonesian Version Total 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 28 Jul 2026.