RecruitingPhase 2

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

China60 participantsStarted 2025-08-27

Plain-language summary

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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18 to 75 years, inclusive, regardless of gender.
. Diagnosis of acute ischemic stroke (AIS).
. Onset time ≤ 72 hours.
. Anterior circulation cerebral infarction.
. Modified Rankin Scale (mRS) score ≤ 1 before the onset of this stroke.
. National Institutes of Health Stroke Scale (NIHSS) score between 8 and 20 (inclusive) at screening, and NIHSS item 1a (level of consciousness) score ≤ 1.
. The subject or their legal guardian has signed the informed consent form.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of subjects with an mRS score of 0-2 at different follow-up visits after treatment.

Timeframe: 360 days

The proportion of subjects with an NIHSS improvement of ≥4 points at different follow-up visits after treatment

Timeframe: 90 days

Changes in NIHSS score from baseline at different follow-up visits after treatment

Timeframe: 90 days

Trends in the distribution of mRS scores (0-6) at different follow-up visits after treatment

Timeframe: 360 days

The proportion of subjects with a Barthel Index (BI) score of ≥95 at different follow-up visits after treatment

Timeframe: 360 days

Changes in Fugl-Meyer Motor Function Assessment Scale score from baseline at different follow-up visits after treatment

Timeframe: 360 days

Trial details

NCT IDNCT07084012

SponsorShenzhen Wingor Biotechnology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-05-31

Contact for this trial

XiaohongWang,MD

86-0755-66835786 xiaohong@wingor.net

View on ClinicalTrials.gov More Acute Ischemic Stroke AIS trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 18 to 75 years, inclusive, regardless of gender.
. Diagnosis of acute ischemic stroke (AIS).
. Onset time ≤ 72 hours.
. Anterior circulation cerebral infarction.
. Modified Rankin Scale (mRS) score ≤ 1 before the onset of this stroke.
. National Institutes of Health Stroke Scale (NIHSS) score between 8 and 20 (inclusive) at screening, and NIHSS item 1a (level of consciousness) score ≤ 1.
. The subject or their legal guardian has signed the informed consent form.

Exclusion criteria

What they're measuring

The proportion of subjects with an mRS score of 0-2 at different follow-up visits after treatment.

Timeframe: 360 days

The proportion of subjects with an NIHSS improvement of ≥4 points at different follow-up visits after treatment

Timeframe: 90 days

Changes in NIHSS score from baseline at different follow-up visits after treatment

Timeframe: 90 days

Trends in the distribution of mRS scores (0-6) at different follow-up visits after treatment

Timeframe: 360 days

The proportion of subjects with a Barthel Index (BI) score of ≥95 at different follow-up visits after treatment

Timeframe: 360 days

Changes in Fugl-Meyer Motor Function Assessment Scale score from baseline at different follow-up visits after treatment

Timeframe: 360 days