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

Sponsor

Shanghai East Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04996966

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Heart Disease Lung Injury Non-cardiac Surgery	Biological: human umbilical cord-derived mesenchymal stem cells Other: saline	Phase 1

Detailed Description

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

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control 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.	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.
Experimental: MSCs injection 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.	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.

Arm

Intervention/Treatment

Placebo Comparator: control

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.

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.

Experimental: MSCs injection

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.

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.

Outcome Measures

Primary Outcome Measures

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

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 IL-1β [Before the operation and 7days after the MSCs injection]
The change in venous blood IL-1β after the operation
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 HMGB1 [Before the operation and 7days after the MSCs injection]
The change in venous blood HMGB1 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 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
electrocardiogram [Before the operation, 7days, and 28 days after the MSCs injection]
The change in electrocardiogram 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 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 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.
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 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 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 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 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
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 C-reactive protein (CRP) [Before the operation and 7 days after the MSCs injection]
The change in venous blood CRP after the operation

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.