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

Tongji University

Status and phase: Enrolling; Phase 1

Conditions: Ischemic Heart Disease; Lung Injury; Non-cardiac Surgery

Treatments: Other: saline; Biological: human umbilical cord-derived mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04996966

DFDA-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

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.

Treatment:

Other: saline

MSCs injection

Experimental group

Description:

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.

Treatment:

Biological: human umbilical cord-derived mesenchymal stem cells