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Early administration of allogenic umbilical cord mesenchymal stromal cells in moderate to severe acute ischemic stroke: a randomized controlled trial

Early administration of allogenic umbilical cord mesenchymal stromal cells in severe acute ischemic stroke: a randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021987
Enrollment
Unknown
Registered
2019-03-19
Start date
2019-06-01
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

acute ischemic stroke (moderate to severe)

Interventions

1:Normal saline + standard treatment
2:MSC + standard treatment

Sponsors

The Third Affiliated Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-80 years; 2. Within 72h of the initial onset of symptoms; 3. Patients are diagnosed with acute ischemic stroke, according to the guidelines from American Heart Association/ American Stroke Association. 4. Moderate to severe neurological deficits with modified NIH stroke scale (NIHSS) = 6 points, but = 25 points; 5. Patients and their family members are well informed and agree with the related procedures.

Exclusion criteria

Exclusion criteria: 1. Ischemic stroke due to special causes (like coagulopathy, vasculitis); recurrent stroke within 3 months; 2. Hemorrhagic transformation; 3. Severe consciousness disturbance (lethargy, coma); 4. Cerebral hernia; Status epilepticus; 5. Severe medical conditions (like unstable vital signs; multiple organ failure); 6. Severe complications (such as kidney dysfunction, liver dysfunction, severe infection, myocardial infarction, etc.); 7. Presence of other neurological or psychological diseases; 8. Malignant disease like cancer; 9. Hematological disorders: HGB<90g/L, or WBC<4.0×10^9/L, or coagulopathy (PLT<100×10^9/L); 10. Prone to allergies; 11. Pregnant (or possibly pregnant) or lactating women.

Design outcomes

Primary

MeasureTime frame
mRS score;

Secondary

MeasureTime frame
NIHSS score;CRP;ESR;immune cell subsets in peripheral blood;

Countries

China

Contacts

Public ContactZhengqi Lu

Department of Neurology, The Third Affiliated Hospital, Sun Yat-Sen University

lzq1828@163.com+86 13570102668

Outcome results

None listed

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