Actively Recruiting
A Phase IIa Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Intravenous Human Umbilical Cord Mesenchymal Stem Cells for Acute Ischemic Stroke
Led by Shenzhen Wingor Biotechnology Co., Ltd. · Updated on 2025-09-29
60
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
Sponsors
S
Shenzhen Wingor Biotechnology Co., Ltd.
Lead Sponsor
B
Beijing Tiantan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to assess the effectiveness and safety of intravenous infusions of human umbilical cord mesenchymal stem cells (hUC-MSCs) in adults with acute ischemic stroke (AIS). AIS is a leading cause of death and disability worldwide, with limited treatment options due to narrow therapeutic time windows and potential complications from current therapies like thrombolysis and thrombectomy. This study evaluates single and multiple infusions of hUC-MSCs to address these challenges and improve recovery outcomes. Participants are randomly assigned to one of three groups: a high-dose hUC-MSC group receiving a single infusion on Day 0 followed by placebo infusions on Days 7 and 14; a low-dose hUC-MSC group receiving three infusions on Days 0, 7, and 14; or a placebo group receiving three infusions of cell medium on the same schedule. The study is double-blinded and placebo-controlled, designed to compare the efficacy and safety between these treatment regimens over time. During the study, participants will be monitored through various clinical assessments including the modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), Barthel Index, and Fugl-Meyer Motor Function Assessment at multiple follow-up visits up to 360 days post-treatment. Safety is evaluated by tracking adverse events and mortality rates. This trial includes detailed pharmacokinetic and pharmacodynamic studies and aims to provide comprehensive data on treatment impact, safety, and tolerability over one year.
CONDITIONS
Brief Title
A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years, inclusive
- Diagnosis of acute ischemic stroke (AIS)
- Stroke onset within 72 hours
- Anterior circulation cerebral infarction
- Modified Rankin Scale (mRS) score 0 or 1 before this stroke
- NIH Stroke Scale (NIHSS) score between 8 and 20 at screening, with level of consciousness score 1 or less
- Signed informed consent by participant or legal guardian
You will not qualify if you...
- Planned or prior thrombolysis or thrombectomy for this stroke
- History of epilepsy (unless secondary epilepsy without current medication), Parkinson's disease, Alzheimer's disease, severe depression, or other conditions affecting participation or efficacy assessment
- Presence of intracranial hemorrhagic diseases (e.g., intracerebral hemorrhage, subarachnoid hemorrhage)
- Large ischemic area or midline shift >1 cm on head CT/MRI indicating poor prognosis or surgical need
- Brain tumor or history of malignancy
- Liver or kidney insufficiency (elevated liver enzymes or low kidney function)
- Severe cardiovascular disease deemed unsuitable by investigator
- Severe infections such as sepsis or severe pneumonia
- Use of systemic corticosteroids (>10 mg prednisone equivalent) or immunosuppressive drugs within 14 days before or during trial
- History of alcohol abuse in past year (more than 2 units per day)
- Pregnant or breastfeeding women, or unwillingness to use reliable contraception or plans for pregnancy or sperm/egg donation
- Participation in other interventional trials within 3 months or prior cell therapy (except blood transfusion)
- Other conditions deemed unsuitable by the investigator including poor compliance or abnormal labs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants receive intravenous infusions of hUC-MSCs or placebo. Depending on the group, participants have either a single infusion or three infusions administered on Day 0, Day 7 (±2 days), and Day 14 (±2 days).
1 to 3 infusion visits depending on group assignment
Duration - Up to 360 days after treatment
Participants are monitored for efficacy and safety outcomes, including stroke recovery assessments and adverse events.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
Research Team
X
XiaohongWang,MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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