Skip to content

A single-center randomized controlled study of human neural stem cell-derived exosomes in the treatment of ischemic stroke

A single-center randomized controlled study of human neural stem cell-derived exosomes in the treatment of ischemic stroke

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200057303
Enrollment
Unknown
Registered
2022-03-07
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-10-09

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

Conditions

Ischemic Stroke

Interventions

Treatment group:Exosomes
Control group:Saline

Sponsors

Integrated Hospital of Traditional Chinese Medicine, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male or female patients from 18 to 70 years of age. 2. Acute unilateral ischemic infarction in the blood supply area of the anterior cerebral artery and/or middle cerebral artery within one month before enrollment. 3. NIHSS score >=6 with monoplegia or hemiplegia (>=1 upper or lower limb movement disorder). 4. Adjusted Rankin score between 2-5. 5. At least 1 cm infarction was confirmed by MRI. 6. Sign the informed consent. 7. Consent and be able to complete follow-up.

Exclusion criteria

Exclusion criteria: 1. History of >=2 symptomatic strokes, excluding TIA; 2. Any examination detected infarction greater than 8cm; 3. Acute coronary events within 3 months before and after stroke onset; 4. MMSE<24 points; 5. History of epilepsy, or taking antiepileptic drugs; 6. Current or previous cell, or exosome therapy (except blood transfusion); 7. Gastrointestinal or other serious bleeding disorders within one month; 8. History of major surgery one week before admission; 9. Those who have the following mergers: (1) Bleeding or coagulation disorder; (2) Severe liver and kidney damage; (3) Mental disorder; (4) Combined malignancy, or a history of malignancy; (5) Primary or secondary immunodeficiency; 10. Pregnant or breastfeeding women; 11. Those who have participated in other clinical trials in the past 3 months; 12. Those deemed inappropriate by the investigators.

Design outcomes

Primary

MeasureTime frame
Incidence of emergency treatment events;Modified Rankin Scale;Changes of brain MRI after treatment;

Countries

China

Contacts

Public ContactChen Lukui

Integrated Hospital of Traditional Chinese Medicine, Southern Medical University

18761886190@163.com+86 187 6188 6190

Outcome results

None listed

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