Back to resultsEffect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury
Primary Purpose
Ischemic Heart Disease, Lung Injury, Non-cardiac Surgery
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
human umbilical cord-derived mesenchymal stem cells
saline
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring human umbilical cord-derived mesenchymal stem cells, lung injury
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.
Sites / Locations
- Shanghai East Hospital, Shanghai Tongji UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
control
MSCs injection
Arm 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.
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.
Outcomes
Primary Outcome Measures
oxygenation index
The change in oxygenation index after the operation
Secondary Outcome Measures
The value of arterial blood cLAC
The change in arterial blood cLAC after the operation
The content of IL-1β
The change in venous blood IL-1β after the operation
The content of IL-6
The change in venous blood IL-6 after the operation
The content of TGF-α
The change in venous blood TGF-α after the operation
The content of HMGB1
The change in venous blood HMGB1 after the operation
The content of IL-10
The change in venous blood IL-10 after the operation
The content of B-type natriuretic peptide (BNP)
The change in venous blood B-type natriuretic peptide after the operation
electrocardiogram
The change in electrocardiogram after the operation
The average length of stay in hospital
The change in the length of stay in hospital between the two groups
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.
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.
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.
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.
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.
The incidence of allergic reaction
The allergic reaction after the MSCs injection
The body temperature
The body temperature before and after the operation
The pulse rate
The pulse rate before and after the operation
The respiration rate
The respiration rate before and after the operation
The blood pressure
The blood pressure before and after the operation
The content of C-reactive protein (CRP)
The change in venous blood CRP after the operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04996966
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Lung Injury, Non-cardiac Surgery
Keywords
human umbilical cord-derived mesenchymal stem cells, lung injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Placebo Comparator
Arm 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.
Arm Title
MSCs injection
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
human umbilical cord-derived mesenchymal stem cells
Intervention 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.
Intervention Type
Other
Intervention Name(s)
saline
Intervention 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.
Primary Outcome Measure Information:
Title
oxygenation index
Description
The change in oxygenation index after the operation
Time Frame
Before the operation, 6 hours, 3days, and 7days after the MSCs injection
Secondary Outcome Measure Information:
Title
The value of arterial blood cLAC
Description
The change in arterial blood cLAC after the operation
Time Frame
Before the operation and 7days after the MSCs injection
Title
The content of IL-1β
Description
The change in venous blood IL-1β after the operation
Time Frame
Before the operation and 7days after the MSCs injection
Title
The content of IL-6
Description
The change in venous blood IL-6 after the operation
Time Frame
Before the operation and 7days after the MSCs injection
Title
The content of TGF-α
Description
The change in venous blood TGF-α after the operation
Time Frame
Before the operation and 7days after the MSCs injection
Title
The content of HMGB1
Description
The change in venous blood HMGB1 after the operation
Time Frame
Before the operation and 7days after the MSCs injection
Title
The content of IL-10
Description
The change in venous blood IL-10 after the operation
Time Frame
Before the operation and 7days after the MSCs injection
Title
The content of B-type natriuretic peptide (BNP)
Description
The change in venous blood B-type natriuretic peptide after the operation
Time Frame
Before the operation and 7days after the MSCs injection
Title
electrocardiogram
Description
The change in electrocardiogram after the operation
Time Frame
Before the operation, 7days, and 28 days after the MSCs injection
Title
The average length of stay in hospital
Description
The change in the length of stay in hospital between the two groups
Time Frame
The average length of stay in hospital
Title
The visual analog scale（VAS）score
Description
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.
Time Frame
Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Title
The hospital for special surgery (HSS) Knee Score
Description
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.
Time Frame
Before the operation, 7days, and 28 days after the MSCs injection
Title
The New York Heart Association (NYHA) Functional Classification
Description
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.
Time Frame
Before the operation, 7days, 14 days, and 28 days after the MSCs injection
Title
The 36-Item Short Form Survey (SF-36)
Description
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.
Time Frame
Before the operation and 28 days after the MSCs injection
Title
The Hamilton Anxiety Scale
Description
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.
Time Frame
Before the operation, 7days, 14 days, and 28 days after the MSCs injection
Title
The incidence of allergic reaction
Description
The allergic reaction after the MSCs injection
Time Frame
Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Title
The body temperature
Description
The body temperature before and after the operation
Time Frame
Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Title
The pulse rate
Description
The pulse rate before and after the operation
Time Frame
Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Title
The respiration rate
Description
The respiration rate before and after the operation
Time Frame
Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Title
The blood pressure
Description
The blood pressure before and after the operation
Time Frame
Before the operation, 6 hours, 3 days, 7days, 14 days, and 28 days after the MSCs injection
Title
The content of C-reactive protein (CRP)
Description
The change in venous blood CRP after the operation
Time Frame
Before the operation and 7 days after the MSCs injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangrui Wang
Phone
+86-021-38804518-22198
Email
xiangruiwang@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lijun Liao
Phone
+86-021-38804518-22198
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiangrui Wang
Organizational Affiliation
Shanghai East Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital, Shanghai Tongji University
City
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongmin Liu
Phone
+86-021-38804518
Email
liu.zhongmin@tongji.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Human Umbilical Cord-derived Mesenchymal Stem Cells on Non-cardiac Surgery-induced Lung Injury
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