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Umbilical cord blood mononuclear cells for ischemic stroke: A multicenter, randomized controlled trial

Umbilical cord blood mononuclear cells for ischemic stroke: A multicenter, randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055541
Enrollment
Unknown
Registered
2022-01-11
Start date
2022-01-11
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Ischemic stroke

Interventions

Experimental group:Cord blood mononuclear cells were infused on the basis of standardized treatment
Control group:Placebo infusion was performed on the basis of standardized treatment

Sponsors

The Second People's Hospital of Shandong
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 35 to 75 years old; 2. Subacute stage of ischemic stroke (1-3 months after stroke); 3. Brain imaging showed ischemic lesions in the anterior circulation; 4. NIHSS score: 7-21; 5. Able to receive or carry out neurological evaluation and rehabilitation treatment; 6. Patients or family members gave informed consent and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Hemorrhagic stroke or symptomatic hemorrhagic transformation; 2. Mrs score > 2 before onset, and the condition deteriorated within 72 hours before enrollment (NIHSS score increased by 4 or more); 3. Chronic liver disease, liver and kidney dysfunction, elevated ALT (3 times higher than the upper limit of normal value), elevated serum creatinine (2 times higher than the upper limit of normal value); 4. Severe cardiopulmonary disease or malignant tumor, and the researcher believes that it is not suitable to participate in this study; 5. Patients whose life expectancy is less than 12 months or who are unable to complete the study for other reasons; 6. Those who have a history of drug or food allergy and are known to be allergic to the drug components of this study; 7. Women of childbearing age who have negative pregnancy test but refuse to take effective contraceptive measures; Pregnant or lactating women; 8. Participate in clinical studies of other investigational drugs within the last 30 days; 9. Inability to understand and / or comply with the study procedures and / or follow-up due to mental illness, cognitive or emotional disorders; 10. It is associated with other autoimmune diseases such as active stage, pulmonary infection or other systemic acute infectious diseases. Human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV), hepatitis B virus (HBV) and hepatitis C virus (HCV) were positive.

Design outcomes

Primary

MeasureTime frame
ModifiedRankin Scale, mRS;

Secondary

MeasureTime frame
National Institute of Health stroke scale, NIHSS;Fugl-Meyer Assessment;Mini-Mental State Examination, MMSE;EuroQol (Quality of life) - 5 Dimensions, EQ-5D;Barthel Index;Peripheral blood CRP;erythrocyte sedimentation rate;Hemagglutination;Blood homocysteine;TNF-a;IL-1ß;IL-6;

Countries

China

Contacts

Public ContactZhang Qinghua

The Second People's Hospital of Shandong

Zhang.qinghua@outlook.com+86 15168863112

Outcome results

None listed

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