Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07084012

A Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of Intravenous Infusion of hUC-MSCs in Patients With AIS

Led by Shenzhen Wingor Biotechnology Co., Ltd. · Updated on 2025-09-29

60

Participants Needed

1

Research Sites

66 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 is a Phase IIa clinical trial with a three-arm design that utilizes randomization, double-blinding, and placebo control. The primary objective of this study is to evaluate the efficacy of single and multiple intravenous infusions of hUC-MSCs injection in patients with AIS. The secondary objective is to assess the safety and tolerability of single and multiple intravenous infusions of hUC-MSCs injection in patients with AIS. The exploratory objective is to investigate the pharmacokinetic and pharmacodynamic characteristics of hUC-MSCs injection in patients with AIS.

CONDITIONS

Official 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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years, inclusive
  • Diagnosis of acute ischemic stroke (AIS)
  • Stroke onset time is 72 hours or less
  • Stroke involves anterior circulation cerebral infarction
  • Modified Rankin Scale (mRS) score of 1 or less before this stroke
  • National Institutes of Health Stroke Scale (NIHSS) score between 8 and 20 inclusive, with NIHSS item 1a score of 1 or less
  • Informed consent form signed by the subject or legal guardian
Not Eligible

You will not qualify if you...

  • Planned or prior thrombolysis or thrombectomy for this stroke
  • History of epilepsy (excluding controlled secondary epilepsy), Parkinson's disease, Alzheimer's disease, severe depression, or other conditions affecting participation or efficacy assessment
  • Presence of intracranial hemorrhagic disease (e.g., intracerebral hemorrhage, subarachnoid hemorrhage, hematomas)
  • Large ischemic area or midline shift greater than 1 cm on head CT or MRI suggesting high likelihood of surgery or poor prognosis
  • Brain tumor or history of cancer
  • Liver or kidney insufficiency with AST or ALT over 2.5 times normal or eGFR under 60 mL/min/1.73 m2
  • History of severe cardiovascular disease deemed unsuitable by investigator
  • Severe infections such as sepsis or severe pneumonia
  • Use of systemic corticosteroids over 10 mg/day prednisone equivalent or immunosuppressive drugs within 14 days before or during the trial
  • History of alcohol abuse within the past year (more than 2 units per day on average)
  • Pregnant or breastfeeding women, or unwillingness to use reliable contraception or plans for pregnancy or sperm/egg donation
  • Participation in another interventional clinical trial within 3 months or prior cell therapy (except transfusion)
  • Other conditions deemed by the investigator to make the patient unsuitable for the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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Research Team

X

XiaohongWang,MD

CONTACT

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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