Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury
NCT ID: NCT04996966
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
16 participants
INTERVENTIONAL
2021-08-01
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
80 Years
ALL
No
Sponsors
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Shanghai East Hospital
OTHER
Responsible Party
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Principal Investigators
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Xiangrui Wang
Role: PRINCIPAL_INVESTIGATOR
Shanghai East Hospital
Locations
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Shanghai East Hospital, Shanghai Tongji University
Shanghai, , China
Countries
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Central Contacts
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Lijun Liao
Role: CONTACT
Phone: +86-021-38804518-22198
Facility Contacts
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Zhongmin Liu
Role: primary
Other Identifiers
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DFDA-001
Identifier Type: -
Identifier Source: org_study_id