Back to resultsTreatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)
Primary Purpose
Myocardial Ischemia, Ventricular Dysfunction, Left
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring Human Umbilical Cord Mesenchymal Stem Cells, Heart Failure
Eligibility Criteria
Inclusion Criteria:
- The patients with coronary heart disease, the effect of drug treatment is not good, and the clinical manifestations of left ventricular insufficiency occur, EF<40%;
- Coronary angiography confirmed that there is a chronic occlusive disease of the coronary artery, which is manifested as severe stenosis of single or multiple coronary vessels (≥75%), or even complete occlusion;
- After the doctor explained the treatment process and possible toxic and side effects, he was willing to treat and agreed to cooperate in the observation of the efficacy. But patients can withdraw from clinical trials and long-term follow-up observation at any time and unconditionally;
- The patient has no mental illness and language dysfunction and can fully understand the treatment method.
Exclusion Criteria:
- Does not meet the above selection criteria;
- Unable to sign the informed consent form, unable to comply with the agreed timetable of this study;
- There are reasons to suspect that the patient was forced to join the trial;
- Acute left ventricular insufficiency, cardiogenic shock;
- The patient has any infectious diseases (including bacterial and viral infections);
- 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
Experimental
No Intervention
Arm Label
CABG with hUC-MSC treatment group
CABG group
Arm Description
In the CABG with hUC-MSC treatment group, 1×10^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG.
CABG was performed under general anesthesia.
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction
The change in Left ventricular ejection fraction (LVEF) % after the operation
Left ventricular end diastolic volume
The change in Left ventricular end diastolic volume (LVEDV) ml after the operation
Left ventricular end systolic volume
The change in Left ventricular end systolic volume (LVESV) ml after the operation
Stroke volume
The change in Stroke volume (SV) ml after the operation
Left ventricular apex four-chamber end systolic diameter
The change in Left ventricular apex four-chamber end systolic diameter (LVESD) mm after the operation
6 minutes walking distance
The change in 6 minutes walking distance m after the operation
Secondary Outcome Measures
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF
The change in THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF after the operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04939077
Brief Title
Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)
Official Title
Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
July 31, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (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 heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.
Detailed Description
This study is an exploratory clinical study to observe the improvement of heart function before and after the treatment by human umbilical cord mesenchymal stem cells, and the purpose is to evaluate the safety and effectiveness of human umbilical cord mesenchymal stem cells in the treatment of heart failure. The study is a randomized parallel controlled study. The research process is as follows: 1. Twenty eligible patients with ischemic heart disease were recruited, fully informed, and signed a consent form, and randomly divided into CABG group (n=10) or CABG + stem cell treatment group (n=10); 2. CABG was performed under general anesthesia in both groups. In the cell therapy group, 1×10^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG; 3. Use vasoactive drugs and antibiotics to prevent infection one week after surgery. After the operation, before discharge, 1 month, 3 months, 6 months, 12 months after discharge, and once a year thereafter, until the death of the patient. Patients receive a review of which main content includes symptom improvement, cardiac function improvement, and adverse events.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Ventricular Dysfunction, Left
Keywords
Human Umbilical Cord Mesenchymal Stem Cells, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CABG with hUC-MSC treatment group
Arm Type
Experimental
Arm Description
In the CABG with hUC-MSC treatment group, 1×10^7 human umbilical cord Mesenchymal Stem Cells were injected to the edge of the myocardial infarction area at 20 points at the same time in CABG.
Arm Title
CABG group
Arm Type
No Intervention
Arm Description
CABG was performed under general anesthesia.
Intervention Type
Biological
Intervention Name(s)
Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
Intervention Description
In CABG with hUC-MSC treatment group, 1×10^7 Human Umbilical Cord Mesenchymal Stem Cells were injected at the edge of the myocardial infarction area at 20 points at the same time in CABG
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Description
The change in Left ventricular ejection fraction (LVEF) % after the operation
Time Frame
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Title
Left ventricular end diastolic volume
Description
The change in Left ventricular end diastolic volume (LVEDV) ml after the operation
Time Frame
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Title
Left ventricular end systolic volume
Description
The change in Left ventricular end systolic volume (LVESV) ml after the operation
Time Frame
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Title
Stroke volume
Description
The change in Stroke volume (SV) ml after the operation
Time Frame
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Title
Left ventricular apex four-chamber end systolic diameter
Description
The change in Left ventricular apex four-chamber end systolic diameter (LVESD) mm after the operation
Time Frame
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Title
6 minutes walking distance
Description
The change in 6 minutes walking distance m after the operation
Time Frame
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Secondary Outcome Measure Information:
Title
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF
Description
The change in THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF after the operation
Time Frame
Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
10. Eligibility
Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients with coronary heart disease, the effect of drug treatment is not good, and the clinical manifestations of left ventricular insufficiency occur, EF<40%;
Coronary angiography confirmed that there is a chronic occlusive disease of the coronary artery, which is manifested as severe stenosis of single or multiple coronary vessels (≥75%), or even complete occlusion;
After the doctor explained the treatment process and possible toxic and side effects, he was willing to treat and agreed to cooperate in the observation of the efficacy. But patients can withdraw from clinical trials and long-term follow-up observation at any time and unconditionally;
The patient has no mental illness and language dysfunction and can fully understand the treatment method.
Exclusion Criteria:
Does not meet the above selection criteria;
Unable to sign the informed consent form, unable to comply with the agreed timetable of this study;
There are reasons to suspect that the patient was forced to join the trial;
Acute left ventricular insufficiency, cardiogenic shock;
The patient has any infectious diseases (including bacterial and viral infections);
Others who are clinically considered unsuitable for this treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongmin Liu, Doctor
Phone
+86-021-38804518
Email
liu.zhongmin@tongji.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongmin Liu, Doctor
Organizational Affiliation
Shanghai East Hospital, Shanghai Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai East Hospital, Shanghai Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongmin Liu, Doctor
Phone
+86-021-38804518
Email
liu.zhongmin@tongji.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)
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