Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury in Patients With Ischemic Heart Disease
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- oxygenation index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
oxygenation index
Time Frame: Before the operation, 6 hours, 3days, and 7days after the MSCs injection
The change in oxygenation index after the operation
Secondary Outcomes
- The content of HMGB1(Before the operation and 7days after the MSCs injection)
- The average length of stay in hospital(The average length of stay in hospital)
- The visual analog scale（VAS）score(Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection)
- The body temperature(Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection)
- The pulse rate(Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection)
- The blood pressure(Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection)
- The content of IL-1β(Before the operation and 7days after the MSCs injection)
- The hospital for special surgery (HSS) Knee Score(Before the operation, 7days, and 28 days after the MSCs injection)
- The incidence of allergic reaction(Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection)
- The value of arterial blood cLAC(Before the operation and 7days after the MSCs injection)
- The content of B-type natriuretic peptide (BNP)(Before the operation and 7days after the MSCs injection)
- The Hamilton Anxiety Scale(Before the operation, 7days, 14 days, and 28 days after the MSCs injection)
- The content of IL-6(Before the operation and 7days after the MSCs injection)
- The content of TGF-α(Before the operation and 7days after the MSCs injection)
- The content of IL-10(Before the operation and 7days after the MSCs injection)
- The New York Heart Association (NYHA) Functional Classification(Before the operation, 7days, 14 days, and 28 days after the MSCs injection)
- electrocardiogram(Before the operation, 7days, and 28 days after the MSCs injection)
- The 36-Item Short Form Survey (SF-36)(Before the operation and 28 days after the MSCs injection)
- The content of C-reactive protein (CRP)(Before the operation and 7 days after the MSCs injection)
- The respiration rate(Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection)