A Phase I Trial of Umbilical Cord Mesenchymal Stromal Cells for Acute Ischemic Stroke (NCT07628933) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Trial of Umbilical Cord Mesenchymal Stromal Cells for Acute Ischemic Stroke
China35 participantsStarted 2026-06-30
Plain-language 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.
Who can participate
Age range
18 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.
. 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.
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
1
Incidence of DLT (Dose-Limiting Toxicity) events;
Timeframe: Day28
2
All adverse events/serious adverse events during the trial;