Umbilical cord stem cells tested in stroke patients
NCT ID NCT07628933
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests whether stem cells from human umbilical cords are safe and might help people recover from a severe stroke. About 35 adults who had a stroke within the last 48 hours will receive either the stem cells or a placebo. The study will check for side effects and measure disability levels over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- human umbilical cord-derived mesenchymal stromal cells
- What this could lead to
- If safe and effective, this could point toward a new treatment to improve recovery after a stroke.
- What could go wrong
- This is a very early Phase 1 trial with only 35 participants, focused on safety. It is too small and early to know if it works, and stem cell therapies carry risks like immune reactions.
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
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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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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 years and older
- 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: * Age ≥18 years, both genders included. * Clinical diagnosis of anterior circulation ischemic stroke, and able to receive the investigational product within 48 hours after the onset of stroke symptoms. * National Institutes of Health Stroke Scale (NIHSS) score of 6-20 (inclusive), with a score of \<2 on item Ia of the NIHSS. * Pre-stroke modified Rankin Scale (mRS) score ≤1. * The participant voluntarily agrees to participate in this study, signs the informed consent form personally or via a legal guardian, and has good compliance. Exclusion Criteria: * Planned or already performed thrombectomy for the current stroke. * Treatment with neuroprotective agents after the current stroke. * History of cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation after the current ischemic stroke, and judged by the investigator to be unsuitable for participation in the clinical trial. * Uncontrolled systemic diseases, including but not limited to: hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure ≥100 mmHg), diabetes mellitus (acute diabetic complications such as ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, or hypoglycemic coma within the past 3 months, or glycated hemoglobin \>8.5%, or poorly controlled blood glucose \[blood glucose \>16.8 mmol/L or \<2.8 mmol/L\]), renal disease (eGFR \<30 mL/min), liver failure (Child-Pugh Class C), severe heart failure (New York Heart Association \[NYHA\] Class IV), severe chronic respiratory disease. * Organ function meeting any one or more of the following criteria: 1. Absolute neutrophil count (ANC) \<1.5×10⁹/L, platelet count (PLT) \<100×10⁹/L, hemoglobin (Hb) \<90 g/L; 2. Aspartate aminotransferase (AST) \>2.5× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>2.5×ULN, serum total bilirubin (TBIL) \>1.5×ULN; 3. Creatinine (Cr) \>1.5×ULN; 4. For patients not receiving anticoagulant or antithrombotic therapy: international normalized ratio (INR) \>1.7 or activated partial thromboplastin time (APTT) \>1.25×ULN; for patients receiving anticoagulant or antithrombotic therapy: INR \>3.0 or APTT \>1.5×ULN. * Diagnosis of immunodeficiency disease, or long-term use of immunosuppressants or systemic corticosteroids at high doses within a short period before screening. * Epilepsy, Alzheimer's disease, Parkinson's disease, severe depression, or other neurological or psychiatric disorders that, in the investigator's opinion, could affect the participant's ability to participate in the trial or interfere with study assessments. * Presence of autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.). * Inability to undergo cranial CT/MRI examination for any reason (e.g., metallic implants such as cardiac pacemakers, claustrophobia, etc.). * Participation in another clinical trial of an investigational drug within 3 months before screening. * Pregnancy, breastfeeding, planned pregnancy, or inability to use effective contraceptive measures. * Any other condition that, in the investigator's judgment, makes the participant unsuitable for inclusion in this study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a kidney protein drug boost stroke recovery after clot removal?
- Can PET scans reveal hidden heart inflammation after a stroke?
- Can an implanted heart monitor catch hidden irregular heartbeats after stroke?
- China builds national watchdog for brain blood vessel devices
- Cancer patients face a hidden Second-Stroke threat, and 24 hospitals are mapping it
- Can tiny neural exosomes help the brain heal after a severe stroke?