Using stem cells from umbilical cords to improve lung function after non-cardiac surgery
Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury in Patients With Ischemic Heart Disease
PHASE1 · Shanghai East Hospital · NCT04996966
This study is testing whether stem cells from umbilical cords can help improve lung function in people with heart disease after they have non-heart surgery like knee replacement.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai East Hospital (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04996966 on ClinicalTrials.gov |
What this trial studies
This exploratory clinical study aims to evaluate the safety and effectiveness of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in improving lung function in patients with ischemic heart disease who undergo non-cardiac surgery. Sixteen eligible patients will be randomly assigned to receive either hUC-MSCs or a placebo after knee replacement surgery. The study will assess symptom improvement, lung function, and any adverse events at multiple time points following treatment. The goal is to determine if hUC-MSCs can mitigate lung injury induced by surgery.
Who should consider this trial
Good fit: Ideal candidates are patients with ischemic heart disease scheduled for their first knee replacement surgery.
Not a fit: Patients with malignant tumors, serious systemic diseases, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve lung function and recovery outcomes for patients undergoing non-cardiac surgery.
How similar studies have performed: While the use of stem cells in various conditions has shown promise, this specific application is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai
- Shanghai East Hospital, Shanghai Tongji University — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Xiangrui Wang — Shanghai East Hospital
- Study coordinator: Xiangrui Wang
- Email: xiangruiwang@vip.sina.com
- Phone: +86-021-38804518-22198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Heart Disease, Lung Injury, Non-cardiac Surgery, human umbilical cord-derived mesenchymal stem cells, lung injury