Clinical trial NCT04996966: Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury
Official title: Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury in Patients With Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Ischemic Heart Disease
Lung Injury
Non-cardiac Surgery
Keywords: human umbilical cord-derived mesenchymal stem cells
lung injury
Lead sponsor: Shanghai East Hospital
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 16
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: oxygenation index
timeFrame: Before the operation, 6 hours, 3days, and 7days after the MSCs injection
Secondary outcomes:
measure: The value of arterial blood cLAC
timeFrame: Before the operation and 7days after the MSCs injection
measure: The content of IL-1β
timeFrame: Before the operation and 7days after the MSCs injection
measure: The content of IL-6
timeFrame: Before the operation and 7days after the MSCs injection
measure: The content of TGF-α
timeFrame: Before the operation and 7days after the MSCs injection
measure: The content of HMGB1
timeFrame: Before the operation and 7days after the MSCs injection
measure: The content of IL-10
timeFrame: Before the operation and 7days after the MSCs injection
measure: The content of B-type natriuretic peptide (BNP)
timeFrame: Before the operation and 7days after the MSCs injection
measure: electrocardiogram
timeFrame: Before the operation, 7days, and 28 days after the MSCs injection
measure: The average length of stay in hospital
timeFrame: The average length of stay in hospital
measure: The visual analog scale（VAS）score
timeFrame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
measure: The hospital for special surgery (HSS) Knee Score
timeFrame: Before the operation, 7days, and 28 days after the MSCs injection
measure: The New York Heart Association (NYHA) Functional Classification
timeFrame: Before the operation, 7days, 14 days, and 28 days after the MSCs injection
measure: The 36-Item Short Form Survey (SF-36)
timeFrame: Before the operation and 28 days after the MSCs injection
measure: The Hamilton Anxiety Scale
timeFrame: Before the operation, 7days, 14 days, and 28 days after the MSCs injection
measure: The incidence of allergic reaction
timeFrame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
measure: The body temperature
timeFrame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
measure: The pulse rate
timeFrame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
measure: The respiration rate
timeFrame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
measure: The blood pressure
timeFrame: Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
measure: The content of C-reactive protein (CRP)
timeFrame: Before the operation and 7 days after the MSCs injection
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai East Hospital, Shanghai Tongji University
Study officials:
affiliation: Shanghai East Hospital
name: Xiangrui Wang
role: PRINCIPAL_INVESTIGATOR
References: