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Exosome in acute ischemic stroke

Safety and feasibility of systemic intravenous infusion of mesenchymal stem cell-derived exosomes in patients with acute ischemic stroke

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200502047277N9
Enrollment
9
Registered
2022-09-17
Start date
2022-09-23
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral infarction. Cerebral infarction

Interventions

Intervention group: All patients (n=9) will be assigned to the single study intervention group. The process of exosome isolation and preparation will be performed in a clinical-grade cleanroom and in

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 80 years Diagnosis of acute ischemic stroke based on clinical and imaging evidence within 24 to 72 h after the onset Baseline National Institutes of Health Stroke Scale (NIHSS) score between 6 and 20

Exclusion criteria

Exclusion criteria: Diagnosis of lacunar or brainstem stroke Acute intracranial hemorrhage History of seizure or current therapy with anti-epileptic medications Any history of traumatic brain injury Any uncontrolled comorbidity, such as diabetes, hepatic, renal, or cardiac failure Ischemic stroke or myocardial infarction within the last 6 months Abnormal renal, hepatic, immunologic, and coagulation profiles Pregnancy and lactation

Design outcomes

Primary

MeasureTime frame
Safety profile of the study intervention. Timepoint: Daily during the first 7 days after the injection and weekly until 3-month after the injection. Method of measurement: Monitoring and evaluating the patients regarding the adverse events.

Secondary

MeasureTime frame
National Institutes of Health Stroke Scale (NIHSS). Timepoint: 1-, 3-, and 6-month after the injection. Method of measurement: Physical examination.;Modified Rankin scale (mRS). Timepoint: 1-, 3-, and 6-month after the injection. Method of measurement: Evaluation of patient.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRoozbeh Tavanaei

Shahid Beheshti University of Medical Sciences

rtavanaei@sbmu.ac.ir+98 21 2270 1022

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026