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

Phase 1

• Conditions: Myocardial Ischemia; Ventricular Dysfunction, Left
• Interventions: Biological: Allogeneic Human Umbilical Cord Mesenchymal Stem Cells

• Registration Number: NCT04939077
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-11-27
• Study First Submitted: 2020-12-03
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-16
• Last Update Submitted: 2021-06-16
• Study First Posted: 2021-06-25
• Last Update Posted: 2021-06-25
• Primary Completion: 2022-07-31
• Study Completion: 2022-11-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CABG with hUC-MSC treatment group	Allogeneic Human Umbilical Cord Mesenchymal Stem Cells	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.

Primary Outcome Measures

Name	Time	Method
Stroke volume	Day 0, Day 30, Day 90, Day 180, Day 360, Day 720	The change in Stroke volume (SV) ml after the operation
Left ventricular ejection fraction	Day 0, Day 30, Day 90, Day 180, Day 360, Day 720	The change in Left ventricular ejection fraction (LVEF) % after the operation
Left ventricular end systolic volume	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
Left ventricular apex four-chamber end systolic diameter	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
Left ventricular end diastolic volume	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
6 minutes walking distance	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

Name	Time	Method
THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF	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

Trial Locations

Locations (1)

Shanghai East Hospital, Shanghai Tongji University; 🇨🇳 Shanghai, Shanghai, China