Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury
- Conditions
- Non-cardiac SurgeryIschemic Heart DiseaseLung Injury
- Interventions
- Other: salineBiological: human umbilical cord-derived mesenchymal stem cells
- Registration Number
- NCT04996966
- Lead Sponsor
- Shanghai East Hospital
- Brief 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.
- Detailed Description
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. The research process is as follows: 1. Sixteen eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into placebo control group (n=8) or hUC-MSCs treatment group (n=8); 2. Knee replacement was performed under general anesthesia in both groups. In the cell therapy group, 1×10\^6/kg human umbilical cord-derived mesenchymal stem cells were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery. Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection, all patients receive a review of which main content includes symptom improvement, lung function improvement, and adverse events.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control saline In the control group, saline containing 2% albumin (2ml/kg) were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery. MSCs injection human umbilical cord-derived mesenchymal stem cells In the MSCs injection group, 1×10\^6/kg human umbilical cord-derived mesenchymal stem cells were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery.
- Primary Outcome Measures
Name Time Method oxygenation index Before the operation, 6 hours, 3days, and 7days after the MSCs injection The change in oxygenation index after the operation
- Secondary Outcome Measures
Name Time Method The blood pressure Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection The blood pressure before and after the operation
The content of HMGB1 Before the operation and 7days after the MSCs injection The change in venous blood HMGB1 after the operation
The average length of stay in hospital The average length of stay in hospital The change in the length of stay in hospital between the two groups
The visual analog scale（VAS）score Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection The change in VAS score after the operation，the minimum value is 0 and the maximum value is 10, the higher scores mean a worse outcome.
The body temperature Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection The body temperature before and after the operation
The pulse rate Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection The pulse rate before and after the operation
The content of IL-1β Before the operation and 7days after the MSCs injection The change in venous blood IL-1β after the operation
The hospital for special surgery (HSS) Knee Score Before the operation, 7days, and 28 days after the MSCs injection The change in HSS Knee Score after the operation, the minimum value is 0 and the maximum value is 100, the higher scores mean a better outcome.
The incidence of allergic reaction Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection The allergic reaction after the MSCs injection
The value of arterial blood cLAC Before the operation and 7days after the MSCs injection The change in arterial blood cLAC after the operation
The content of B-type natriuretic peptide (BNP) Before the operation and 7days after the MSCs injection The change in venous blood B-type natriuretic peptide after the operation
The Hamilton Anxiety Scale Before the operation, 7days, 14 days, and 28 days after the MSCs injection The change in degree of anxiety after the operation, the minimum value is 0 and the maximum value is 56, the higher scores mean a worse outcome.
The content of IL-6 Before the operation and 7days after the MSCs injection The change in venous blood IL-6 after the operation
The content of TGF-α Before the operation and 7days after the MSCs injection The change in venous blood TGF-α after the operation
The content of IL-10 Before the operation and 7days after the MSCs injection The change in venous blood IL-10 after the operation
The New York Heart Association (NYHA) Functional Classification Before the operation, 7days, 14 days, and 28 days after the MSCs injection The change in NYHA Functional Classification after the operation, the lowest level is Class I and the highest level is Class IV, the higher level mean a worse outcome.
electrocardiogram Before the operation, 7days, and 28 days after the MSCs injection The change in electrocardiogram after the operation
The 36-Item Short Form Survey (SF-36) Before the operation and 28 days after the MSCs injection The change in SF-36 after the operation, the minimum value is 40 and the maximum value is 850, the higher scores mean a better outcome.
The content of C-reactive protein (CRP) Before the operation and 7 days after the MSCs injection The change in venous blood CRP after the operation
The respiration rate Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection The respiration rate before and after the operation
Trial Locations
- Locations (1)
Shanghai East Hospital, Shanghai Tongji University
🇨🇳Shanghai, China