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Cord stem cells infused in stroke survivors: safe so far?

NCT ID NCT05697718

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

18 people

The number who actually took part.

Started

Apr 2023

Finished

Aug 2024

Lead sponsor

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

18 to 80 years

Sex

Anyone

Healthy volunteers

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

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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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

  • Xuanwu Hospital of Capital Medical University

    Beijing, Beijing Municipality, China

  • Xuanwu Hospital of Capital Medical University

    Beijing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.