Cord stem cells infused in stroke survivors: safe so far?
NCT ID NCT05697718
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested whether a single intravenous infusion of stem cells from human umbilical cord tissue is safe for people who had an ischemic stroke 3 to 6 months earlier. 18 participants were monitored for side effects and any improvement in daily function. The goal was to see if the treatment is tolerable and might help recovery, not to cure the stroke damage.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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18 people
The number who actually took part.
- Started
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Apr 2023
- Finished
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Aug 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 18 to 80 years old, both sexes; 2. Diagnosed with ischemic stroke of the anterior circulation at 12-24 weeks after the first stroke symptom onset (including W12 and W24); 3. National Institutes of Health Stroke Scale (NIHSS) score 6-20 points, and NlHSS score item 1a \< 2 points; 4. Life expectancy ≥ 12 months; 5. Understand and comply with the study process, with informed consent form voluntarily signed by the patient or the authorized representatives. Exclusion Criteria: 1. Current or previous epilepsy, dementia, Parkinson's disease, major depression, or other neurological disorders or mental illnesses that the investigator believes will affect their ability to participate in the study or affect the study evaluation; 2. Current or past intracranial hemorrhagic diseases (such as: cerebral hemorrhage, epidural hematoma, subdural hematoma, subarachnoid hemorrhage, ventricle hemorrhage, traumatic cerebral hemorrhage, etc.) or cerebral tumors, history of brain trauma, encephalitis and other symptoms leading to apoplexy; 3. Current or past severe cardiovascular disease; 4. Patients with pulmonary embolism, interstitial pneumonia, radiation pneumonia, drug-related pneumonia, severe impairment of lung function and other severe lung infections or other lung diseases (except those caused by stroke, bed rest after stroke or stroke treatment); 5. Have any other clinically serious medical conditions currently or in the past that the investigators judge unsuitable for inclusion in this study, including but not limited to severe liver (e.g., cirrhosis, etc.), kidney (e.g., kidney diseases requiring hemodialysis or peritoneal dialysis, etc.), blood (e.g., hemophilia with bleeding tendencies, etc.), endocrine (e.g.,Diabetes mellitus with difficult blood glucose control (blood glucose \> 16.8mmol/L or \< 2.8mmol/L), or complicated with severe neurovascular complications, etc.), immune system (active or uncontrolled autoimmune diseases, primary or secondary immune deficiencies, etc.), malignant tumors (except cured non-melanoma skin cancer, cervical or breast ductal carcinoma in situ), etc.; 6. Organ function level meet the following any one or more: absolute neutrophil cell count (ANC) \< 1.5×109/L, platelet (PLT) \< 100×109/L, hemoglobin (Hb) \< 90g/L; Aspertate aminotransferase (AST) \> 2.5×normal limit (ULN) and/or alanine aminotransferase (ALT) \> 2.5×ULN, serum total bilirubin (TBIL) \> 1.5×ULN; Creatinine (Cr) \> 1.5×ULN; The international normalized ratio (INR) for those who did not receive anticoagulant or antithrombotic therapy \> 1.7 or activated partial thromboplastin time (APTT) \> 1.25×ULN, the international normalized ratio(INR) for those using anticoagulant or antithrombotic therapy \> 3.0 or activated partial thromboplastin time (APTT) \> 1.50×ULN. 7. Hepatitis B virus surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive for HBV-DNA, positive for hepatitis C virus antibody (HCVAb), treponema pallidum antibody (TPAb/RPR) or human immunodeficiency virus antibody (HIV), or within 14 days prior to receiving the test drug treatment,The emergence of any infected persons in need of systematic anti-infective treatment; 8. Allergic constitution or history, or allergic to the test drug or any component of the test drug; 9. Patients with MRI contraindications; 10. Positive blood pregnancy test results for female subjects of reproductive age within 7 days prior to receiving the experimental drug treatment;All women of reproductive age, fertile men or their spouses who refused to use appropriate contraception (including at least one barrier contraceptive) throughout the study period, and lactating women; 11. Those who required systemic corticosteroids (\> 10mg/ day prednisone therapeutic dose) or other immunosuppressive agents within 14 days prior to receiving the trial drug or during the study period; 12. Patients who used butylphthalein within 3 weeks before receiving the experimental drug; 13. participated in any clinical trial and took any investigational drug within 3 months prior to receiving the investigational drug treatment (or the last time receiving the investigational drug did not exceed 5 half-lives, whichever is longer); 14. Patients who had severe trauma or major surgery within 3 months before receiving the experimental drug treatment, or who plan to undergo surgery during the trial period;Patients with a history of blood transfusion within 3 months before receiving the experimental drug treatment; 15. Those who had a history of drug abuse or alcoholism within 1 year before receiving the experimental drug treatment; 16. Those who have previously received other stem cell treatments; 17. Participants with other severe, acute, or chronic medical conditions that may increase the patient's risk or may interfere with the interpretation of the test results are judged by the investigator to be unsuitable for clinical trials.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Xuanwu Hospital of Capital Medical University
Beijing, Beijing Municipality, China
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Xuanwu Hospital of Capital Medical University
Beijing, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Heart hole or stroke trigger? global registry tracks who gets closure and what happens next
- Two ways to catch a hidden heart rhythm after stroke
- Blood test may reveal who recovers after a stroke
- Can a smart bracelet and app stop a second stroke?
- Pharmacist and coach team takes aim at blood pressure after stroke