Tests umbilical cord stem cell injection in people with acute ischemic stroke
Tests umbilical cord stem cell injection for acute ischemic stroke in adults.
Plain-language title generated from the registry record
Registry title: A Phase I Trial of Umbilical Cord Mesenchymal Stromal Cells for Acute Ischemic Stroke
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
Where in China
- Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BOE Technology Group Co., Ltd.
- Trial code
- NCT07628933
- Record updated
- 5 June 2026
- Original description
Study Methods: The trial consists of two phases, both including a placebo control.Read full original descriptionShow less
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord-derived Mesenchymal Stromal Cell Injection in Patients With Acute Ischemic Stroke (AIS)
Study Methods: The trial consists of two phases, both including a placebo control.
Phase Ia (single-dose, dose-escalation): Three dose groups (low, medium, high) are set. This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial. Dose escalation to the next level is permitted only after safety assessment at 28 days post-dose in the previous group.
Phase Ib (multiple-dose): Based on Phase Ia results, two dose groups will be selected. The product is administered on Day 0, Day 7, and Day 14 (3 doses total). The trial remains randomized, double-blind, and placebo-controlled.
Inclusion: 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: Treatment with neuroprotective agents after the current stroke; Participation in another clinical trial of an investigational drug within 3 months before screening; Planned or already performed thrombectomy for 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; 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.); Any other condition that, in the investigator's judgment, makes the participant unsuitable for inclusion in this study; 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:; Absolute neutrophil count (ANC) <1.5×10⁹/L, platelet count (PLT) <100×10⁹/L, hemoglobin (Hb) <90 g/L; 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; Creatinine (Cr) >1.5×ULN; 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; Pregnancy, breastfeeding, planned pregnancy, or inability to use effective contraceptive measures.