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

NCT04939077 | Unknown Phase 1

• 1 other identifier: MR-31-20-000323
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Ischemia; Ventricular Dysfunction, Left

Keywords

Human Umbilical Cord Mesenchymal Stem Cells; Heart Failure

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• THE WORLD HEALTH ORGANIZATION QUALITY OF LIFE (WHOQOL) -BREF

  Day 0, Day 30, Day 90, Day 180, Day 360, Day 720

Study Arms (2)

CABG with hUC-MSC treatment group

EXPERIMENTAL

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

CABG group

NO INTERVENTION

CABG was performed under general anesthesia.

Interventions

Allogeneic Human Umbilical Cord Mesenchymal Stem Cells BIOLOGICAL

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

CABG with hUC-MSC treatment group

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai East Hospital: lead

Study Sites (1)

Shanghai East Hospital, Shanghai Tongji University

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

MeSH Terms

Conditions

Myocardial Ischemia; Ventricular Dysfunction, Left; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Ventricular Dysfunction

Study Officials

• Zhongmin Liu, Doctor

  Shanghai East Hospital, Shanghai Tongji University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongmin Liu, Doctor

CONTACT

+86-021-38804518; liu.zhongmin@tongji.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: June 25, 2021
• Study Start: November 27, 2019
• Primary Completion: July 31, 2022
• Study Completion: November 30, 2022
• Last Updated: June 25, 2021

Record last verified: 2021-06

Locations

CN (1)