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Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04939077
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai East Hospital

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.

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Ventricular Dysfunction, Left Biological: Allogeneic Human Umbilical Cord Mesenchymal Stem Cells Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Heart Failure Using Human Umbilical Cord Mesenchymal Stem Cells(hUC-MSC)
Actual Study Start Date : November 27, 2019
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CABG with hUC-MSC treatment group
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.
Biological: Allogeneic Human Umbilical Cord Mesenchymal Stem Cells
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

No Intervention: CABG group
CABG was performed under general anesthesia.



Primary Outcome Measures :
  1. Left ventricular ejection fraction [ Time Frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 ]
    The change in Left ventricular ejection fraction (LVEF) % after the operation

  2. Left ventricular end diastolic volume [ Time Frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 ]
    The change in Left ventricular end diastolic volume (LVEDV) ml after the operation

  3. Left ventricular end systolic volume [ Time Frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 ]
    The change in Left ventricular end systolic volume (LVESV) ml after the operation

  4. Stroke volume [ Time Frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 ]
    The change in Stroke volume (SV) ml after the operation

  5. Left ventricular apex four-chamber end systolic diameter [ Time Frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 ]
    The change in Left ventricular apex four-chamber end systolic diameter (LVESD) mm after the operation

  6. 6 minutes walking distance [ Time Frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 ]
    The change in 6 minutes walking distance m after the operation


Secondary Outcome Measures :
  1. THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF [ Time Frame: Day 0, Day 30, Day 90, Day 180, Day 360, Day 720 ]
    The change in THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF after the operation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939077


Contacts
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Contact: Zhongmin Liu, Doctor +86-021-38804518 liu.zhongmin@tongji.edu.cn

Locations
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China, Shanghai
Shanghai East Hospital, Shanghai Tongji University Recruiting
Shanghai, Shanghai, China, 200120
Contact: Zhongmin Liu, Doctor    +86-021-38804518    liu.zhongmin@tongji.edu.cn   
Sponsors and Collaborators
Shanghai East Hospital
Investigators
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Principal Investigator: Zhongmin Liu, Doctor Shanghai East Hospital, Shanghai Tongji University
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Responsible Party: Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT04939077    
Other Study ID Numbers: MR-31-20-000323
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai East Hospital:
Human Umbilical Cord Mesenchymal Stem Cells
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Myocardial Ischemia
Ventricular Dysfunction
Ventricular Dysfunction, Left
Ischemia
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Vascular Diseases