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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Injury; Ischemic Heart Disease; Non-cardiac Surgery
• Intervention / Treatment: Other: saline; Biological: human umbilical cord-derived mesenchymal stem cells

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 Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiangrui Wang; Phone Number: +86-021-38804518-22198; Email: xiangruiwang@vip.sina.com
• Study Contact Backup: Name: Lijun Liao; Phone Number: +86-021-38804518-22198

Study Locations

• China
  • Shanghai, China, 200120
    • Recruiting
    • Shanghai East Hospital, Shanghai Tongji University
    • Contact: Zhongmin Liu; Phone Number: +86-021-38804518; Email: liu.zhongmin@tongji.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygenation index	The change in oxygenation index after the operation	Before the operation, 6 hours, 3days, and 7days after the MSCs injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The value of arterial blood cLAC	The change in arterial blood cLAC after the operation	Before the operation and 7days after the MSCs injection
The content of IL-1β	The change in venous blood IL-1β after the operation	Before the operation and 7days after the MSCs injection
The content of IL-6	The change in venous blood IL-6 after the operation	Before the operation and 7days after the MSCs injection
The content of TGF-α	The change in venous blood TGF-α after the operation	Before the operation and 7days after the MSCs injection
The content of HMGB1	The change in venous blood HMGB1 after the operation	Before the operation and 7days after the MSCs injection
The content of IL-10	The change in venous blood IL-10 after the operation	Before the operation and 7days after the MSCs injection
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
electrocardiogram	The change in electrocardiogram after the operation	Before the operation, 7days, and 28 days after the MSCs injection
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Investigators: Principal Investigator: Xiangrui Wang, Shanghai East Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 17, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: lung injury; human umbilical cord-derived mesenchymal stem cells
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lung Diseases; Coronary Disease; Thoracic Injuries; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Wounds and Injuries; Lung Injury
• Other Study ID Numbers: DFDA-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No