Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury

Ischemic Heart Disease Clinical Trial

Official title:

Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury in Patients With Ischemic Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04996966
• Other study ID #: DFDA-001
• Status: Recruiting
• Phase: Phase 1
• Start date: August 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: Shanghai East Hospital
• Contact: Xiangrui Wang
• Phone: +86-021-38804518-22198
• Email: xiangruiwang[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

Inclusion Criteria:

• The electrocardiogram showed T wave change and ST segment depression
• New York Heart Association (NYHA) Classification of cardiac function ?-? 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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Lung Injury
• Myocardial Ischemia
• Non-cardiac Surgery
• Wounds and Injuries

Intervention

Biological:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
China	Shanghai East Hospital, Shanghai Tongji University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygenation index	The change in oxygenation index after the operation	Before the operation, 6 hours, 3days, and 7days after the MSCs injection
Secondary	The value of arterial blood cLAC	The change in arterial blood cLAC after the operation	Before the operation and 7days after the MSCs injection
Secondary	The content of IL-1ß	The change in venous blood IL-1ß after the operation	Before the operation and 7days after the MSCs injection
Secondary	The content of IL-6	The change in venous blood IL-6 after the operation	Before the operation and 7days after the MSCs injection
Secondary	The content of TGF-a	The change in venous blood TGF-a after the operation	Before the operation and 7days after the MSCs injection
Secondary	The content of HMGB1	The change in venous blood HMGB1 after the operation	Before the operation and 7days after the MSCs injection
Secondary	The content of IL-10	The change in venous blood IL-10 after the operation	Before the operation and 7days after the MSCs injection
Secondary	The content of B-type natriuretic peptide (BNP)	The change in venous blood B-type natriuretic peptide after the operation	Before the operation and 7days after the MSCs injection
Secondary	electrocardiogram	The change in electrocardiogram after the operation	Before the operation, 7days, and 28 days after the MSCs injection
Secondary	The average length of stay in hospital	The change in the length of stay in hospital between the two groups	The average length of stay in hospital
Secondary	The visual analog scale(VAS)score	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.	Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Secondary	The hospital for special surgery (HSS) Knee Score	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.	Before the operation, 7days, and 28 days after the MSCs injection
Secondary	The New York Heart Association (NYHA) Functional Classification	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.	Before the operation, 7days, 14 days, and 28 days after the MSCs injection
Secondary	The 36-Item Short Form Survey (SF-36)	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.	Before the operation and 28 days after the MSCs injection
Secondary	The Hamilton Anxiety Scale	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.	Before the operation, 7days, 14 days, and 28 days after the MSCs injection
Secondary	The incidence of allergic reaction	The allergic reaction after the MSCs injection	Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Secondary	The body temperature	The body temperature before and after the operation	Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Secondary	The pulse rate	The pulse rate before and after the operation	Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Secondary	The respiration rate	The respiration rate before and after the operation	Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Secondary	The blood pressure	The blood pressure before and after the operation	Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Secondary	The content of C-reactive protein (CRP)	The change in venous blood CRP after the operation	Before the operation and 7 days after the MSCs injection