A Phase I Trial of Umbilical Cord Mesenchymal Stromal Cells for Acute Ischemic Stroke

NCT07628933 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: YW2026-016-02
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Ischemic Stroke; AIS

Keywords

AIS; hUC-MSCs

Outcome Measures

Primary Outcomes (3)

• Incidence of DLT (Dose-Limiting Toxicity) events;

  Day28

• All adverse events/serious adverse events during the trial;

  2year

• All-cause mortality

  Day90、Day180、Day360

Secondary Outcomes (6)

• Proportion of participants with an Modified Rankin Scale (mRS) score of 0-2

  Day 30, Day90, Day180, Day360

• Proportion of participants with a ≥4-point improvement in National Institutes of Health Stroke Scale (NIHSS) score from baseline

  Day 7, Day 14, Day 30, Day 90, Day 180, Day 360

• Change from baseline in National Institutes of Health Stroke Scale(NIHSS) score

  Day 7, Day 14, Day 30, Day 90, Day 180, Day 360

• Proportion of participants with a Barthel Index ≥95

  Day 30, Day 90, Day180, Day360

• Change from baseline in the Fugl-Meyer Motor Function Assessment Scale score

  Day 30, Day90, Day180, Day 360

Other Outcomes (1)

• mmunogenicity: Human Leukocyte Antigen (HLA) antibodies.

  Within 60 minutes before the first dose, and at 14 days, 30 days, and 90 days after the start of the first dose administration.

Study Arms (9)

Human Umbilical Cord Mesenchymal Stromal Cells Injection（low-dose group）

EXPERIMENTAL

5.0×10\^7 cells,Single intravenous infusion

Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection

Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group）

EXPERIMENTAL

1.0×10\^8 cells,Single intravenous infusion

Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection

Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group）

EXPERIMENTAL

2.0×10\^8 cells,Single intravenous infusion

Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection

Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group）

PLACEBO COMPARATOR

1.0×10\^8 cells,Single intravenous infusion

Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection

Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group）

PLACEBO COMPARATOR

2.0×10\^8 cells,Single intravenous infusion

Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection

Human Umbilical Cord Mesenchymal Stromal Cells Injection 1

EXPERIMENTAL

Based on the results from the Phase Ia trial, dose group 1 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses.

Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection

Human Umbilical Cord Mesenchymal Stromal Cells Injection 2

EXPERIMENTAL

Based on the results from the Phase Ia trial, dose group 2 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses.

Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection

Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 1

PLACEBO COMPARATOR

Based on the results from the Phase Ia trial, dose group 1 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses.

Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection

Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 2

PLACEBO COMPARATOR

Based on the results from the Phase Ia trial, dose group 2 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses.

Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection

Interventions

Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection DRUG

Placebo refers to a cell-free product, whose packaging, storage conditions, expiration date, and method of administration remain consistent with those of the investigational drug.

Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 1; Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 2; Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group）; Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group）

Human Umbilical Cord Mesenchymal Stem Cells Injection DRUG

the first phase (Phase Ia) is a single-dose administration

Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group）; Human Umbilical Cord Mesenchymal Stromal Cells Injection（low-dose group）; Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group）

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.
• 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.

Sponsors & Collaborators

• BOE Technology Group Co., Ltd.: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yongjun Wang Chief Physician, Professor

CONTACT

010-59978538; yongjunwang111@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): November 30, 2029
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)