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

Shanghai East Hospital16 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Interventions

human umbilical cord-derived mesenchymal stem cellsBIOLOGICAL

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.

salineOTHER

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.

Eligibility

Sex: ALLMin age: 60 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shanghai East Hospital, Shanghai Tongji University

Shanghai, China

RECRUITING

Outcomes

Primary Outcomes

oxygenation index

The change in oxygenation index after the operation

Time frame: Before the operation, 6 hours, 3days, and 7days after the MSCs injection