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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Ischemia; Ventricular Dysfunction, Left
• Intervention / Treatment: Biological: Allogeneic Human Umbilical Cord Mesenchymal Stem Cells

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zhongmin Liu, Doctor; Phone Number: +86-021-38804518; Email: liu.zhongmin@tongji.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200120
      • Recruiting
      • Shanghai East Hospital, Shanghai Tongji University
      • Contact: Zhongmin Liu, Doctor; Phone Number: +86-021-38804518; Email: liu.zhongmin@tongji.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left ventricular ejection fraction	The change in Left ventricular ejection fraction (LVEF) % after the operation	Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular end diastolic volume	The change in Left ventricular end diastolic volume (LVEDV) ml after the operation	Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular end systolic volume	The change in Left ventricular end systolic volume (LVESV) ml after the operation	Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Stroke volume	The change in Stroke volume (SV) ml after the operation	Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
Left ventricular apex four-chamber end systolic diameter	The change in Left ventricular apex four-chamber end systolic diameter (LVESD) mm after the operation	Day 0, Day 30, Day 90, Day 180, Day 360, Day 720
6 minutes walking distance	The change in 6 minutes walking distance m after the operation	Day 0, Day 30, Day 90, Day 180, Day 360, Day 720

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF	The change in THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF after the operation	Day 0, Day 30, Day 90, Day 180, Day 360, Day 720

Collaborators and Investigators

• Sponsor: Shanghai East Hospital
• Investigators: Principal Investigator: Zhongmin Liu, Doctor, Shanghai East Hospital, Shanghai Tongji University

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Anticipated): July 31, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 25, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Heart Failure; Human Umbilical Cord Mesenchymal Stem Cells
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Heart Failure; Myocardial Ischemia; Ischemia; Ventricular Dysfunction; Ventricular Dysfunction, Left
• Other Study ID Numbers: MR-31-20-000323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No