Effect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients (NCT04093336) | Clinical Trial Compass
UnknownPhase 1/2
Effect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients
China120 participantsStarted 2019-01-13
Plain-language summary
This is a placebo controlled, randomized, double blinded study including Phase 1 and Phase 2. Phase I study is a safety assessment and Phase 2 study is incline to assess effectiveness of MSCs. Potential subjects must be screened and consented before enrolled.
The primary objective of this study is to determine the effects of early intravenous infusion of allogeneic human umbilical cord mesenchymal stem cells (HucMSCs or MSCs used in the following section) for patients with acute ischemic stroke. Eligible patients will receive a single dose of MSCs or placebo within 24 hours after stroke. Patients will be followed for 2 years post infusion for safety and efficacy (change in neurological symptoms and quality of life). Assessments will occur during transplantation and at 3,7, 14 days and1,3, 6, 12, 18 and 24 months after infusions of stem cells.
Who can participate
Age range
18 Years – 80 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
. Acute ischemic stroke;
. Age 18\~80y;
. 4≤NIHSS score≤18（including limb score≥2）and modified Rankin scale 0-1 before this cerebral ischemic stroke;
. patients and their families understand and will cooperate within the whole process of study, and sign informed consent;
. any of following items：①acute cerebral infarction confirmed by cerebral CT perfusion or non-contrast computed tomographic scan \< 7 days after onset or ②acute cerebral infarction confirmed by cerebral MR image \< 7 days after onset
Exclusion criteria
. accompanied by hematological disease, severe infection, liver dysfunction (ALT\>3\*ULN), kidney dysfunction (Scr \>2\*ULN), cardiac dysfunction (NYHA grade III or IV);
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.