UC-MSC Transplantation for Left Ventricular Dysfunction After AMI (NCT03902067) | Clinical Trial Compass
WithdrawnPhase 1
UC-MSC Transplantation for Left Ventricular Dysfunction After AMI
Stopped: budget control
China0Started 2024-12-01
Plain-language summary
A pilot study to evaluate the safety and feasibility of umbilical cord mesenchymal stem cells in the treatment of acute myocardial infarction by catheter transplantation
Who can participate
Age range
50 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:
* Patients with acute extensive anterior myocardial infarction were successfully treated with emergency interventional therapy within 12 hours after onset. LVEF was less than 0.35 by echocardiography 30 days after operation, scar area was more than 25% by MRI, and cardiac function was NYHA III-IV grade.
* Fully inform the purpose, method and possible side effects of the test, agree to the test, and sign an informed consent form;
* Good compliance, willing to take drugs and follow up according to the requirements of the plan;
* Life expectancy exceeds one year.
Exclusion Criteria:
* Those who cannot tolerate cell therapy;
* Patients with severe hepatic and renal insufficiency (ALT\>1.5 times the upper limit of normal value, Cr \>1.5 times the upper limit of normal value);
* Patients with malignant tumors or extremely weak patients;
* Patients with severe infection;
* Patients who are expected to have the second coronary intervention or bypass grafting within 3 months;
* Patients with other serious systemic diseases and organ dysfunction;
* Patients with cardiogenic shock;
* Patients with hemorrhagic diseases;
* Researchers believe that anyone who is not suitable for inclusion
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.
1Since this trial has been withdrawn and never completed, what does that mean for my options — are there other stem cell or cell therapy trials for heart damage after a heart attack that my doctor knows about and could refer me to?
2This was a Phase 1 trial focused mainly on safety rather than proving the treatment works — does that mean we still don't know whether UC-MSC transplantation is actually effective for left ventricular dysfunction, and should that affect how I think about pursuing this type of therapy?
3The trial was measuring Major Adverse Cardiac Events as its main safety signal — what kinds of serious cardiac risks were researchers concerned about with this approach, and how does that compare to the risks of standard treatments for reduced heart function after a heart attack?
4Given that this study was withdrawn before producing results, would my doctor recommend I focus first on established treatments for left ventricular dysfunction — like medications or cardiac rehab — rather than waiting for experimental options?
5Are there any active trials or expanded access programs testing umbilical cord stem cell therapy for heart failure after a heart attack that my care team could help me evaluate as an alternative to this withdrawn study?
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
Safety measured as the number of Major Adverse Cardiac Events (MACE)