Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung… (NCT04996966) | Clinical Trial Compass
UnknownPhase 1
Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury
China16 participantsStarted 2021-08-01
Plain-language summary
This study is an exploratory clinical study to observe the improvement of lung function before and after the treatment by human umbilical cord-derived mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells on non-cardiac surgery-induced lung injury in patients with ischemic heart disease. The study is a randomized parallel controlled study. Patients receive a review of which main content includes symptom improvement, lung function improvement, and adverse events.
Who can participate
Age range
60 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:
* The electrocardiogram showed T wave change and ST segment depression
* New York Heart Association (NYHA) Classification of cardiac function Ⅰ-Ⅱ level
* The patient who first time to receive knee replacement
* General anesthesia lasted about 2h
* Signed informed consent
Exclusion Criteria:
* Does not meet the above selection criteria
* Unable to sign the informed consent
* Patients with a malignant tumor, other serious systemic diseases, or psychosis
* Pregnancy, lactation, and those who are not pregnant but do not take effective contraceptives measures
* The patient with a history of an allergic reaction to biological products or drug
* The patient has any infectious diseases (including bacterial and viral infections)
* The patient with cardiac pacemaker implantation within 3 months prior to enrollment
* The patient who had a stroke within 6 months prior to enrollment
* Unable to comply with the agreed timetable of this study
* Patients who are participating in other clinical trials
* Others who are clinically considered unsuitable for this treatment.
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
oxygenation index
Timeframe: Before the operation, 6 hours, 3days, and 7days after the MSCs injection