NCT07731087

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Jul 2026Dec 2026

Study Start

First participant enrolled

July 9, 2026

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 23, 2026

Last Update Submit

July 23, 2026

Conditions

Ischemic StrokePost-Stroke Cognitive Impairment

Keywords

Subacute ischemic strokePost-stroke cognitive impairmentMesenchymal stem cell secretomeMSC secretomeCognitive recoveryMoCA-InaQuantitative electroencephalographyqEEGBrain-derived neurotrophic factorBDNFInterleukin-1 betaIL-1β

Outcome Measures

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.

    Baseline to week 8

Secondary Outcomes (9)

  • Change in Delta-to-Alpha Ratio on Quantitative Electroencephalography

    Baseline, week 4, and week 8

  • Change in Delta-Theta-to-Alpha-Beta Ratio on Quantitative Electroencephalography

    Baseline, week 4, and week 8

  • Change in Relative Alpha Power on Quantitative Electroencephalography

    Baseline, week 4, and week 8

  • Change in Relative Theta Power on Quantitative Electroencephalography

    Baseline, week 4, and week 8

  • Change in Serum Brain-Derived Neurotrophic Factor Concentration

    Baseline and week 8

  • +4 more secondary outcomes

Study Arms (2)

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.

Biological: Umbilical Cord Mesenchymal Stem Cell-Derived SecretomeOther: Standard Stroke Care and Rehabilitation

Standard of Care Alone

ACTIVE COMPARATOR

Participants receive standard medical treatment and standardized stroke rehabilitation without MSC secretome.

Other: Standard Stroke Care and Rehabilitation

Interventions

Umbilical Cord Mesenchymal Stem Cell-Derived SecretomeBIOLOGICAL

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.

Also known as: USEPro
MSC Secretome Plus Standard of Care
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.

MSC Secretome Plus Standard of CareStandard of Care Alone

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasanuddin University Hospital

Makassar, South Sulawesi, 90245, Indonesia

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jumraini Tammasse, Sp.N, Subsp.NRE(K)

    Hasanuddin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jumraini Tammasse, Sp.N, Subsp.NRE(K)

CONTACT

+6282188833368tejayanovi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors responsible for the MoCA-Ina, NIHSS, modified Rankin Scale, and quantitative electroencephalography assessments are blinded to treatment allocation. The randomization sequence and treatment assignment are not disclosed to the outcome assessors
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 28, 2026

Study Start

July 9, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations

ID(1)