NCT04992832

Brief Summary

This study is an exploratory clinical study to observe the safety and efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in the heart failure patients with reduced ejection fraction. The study was a 12 months single center, randomized, double-blind, placebo-controlled trial that included 12 weeks of treatment, and 9 months of follow-up.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

July 28, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
Last Updated

December 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.5 years

First QC Date

July 13, 2021

Last Update Submit

November 30, 2023

Conditions

Heart Failure, Systolic

Keywords

Human Umbilical Cord Mesenchymal Stem CellsHeart Failure

Outcome Measures

Primary Outcomes (2)

  • The safety of treatment

    The incidence of treatment related adverse events

    Day 360

  • Left ventricular ejection fraction

    The change in Left ventricular ejection fraction (LVEF) % after the infusion.

    Day 360

Secondary Outcomes (8)

  • A composite of cardiac death and rehospitalization caused by heart failure within 12 months

    12 month after treatment

  • NT-proBNP

    Day 360

  • ST2

    Day 360

  • Left ventricular end systolic volume

    Day 43, Day 85, Day 180, Day 360

  • 6 minutes walking distance

    Day 360

  • +3 more secondary outcomes

Study Arms (2)

experimental group

EXPERIMENTAL

The volunteers of the experimental group will be given peripheral intravenously a dose of 1.0\*10\^6/kg human umbilical cord mesenchymal stem cells at 0,6,12 week.

Biological: human umbilical cord mesenchymal stem cells

control group

PLACEBO COMPARATOR

The control group will be given the same dose of saline containing human albumin.

Other: human serum albumin

Interventions

human umbilical cord mesenchymal stem cellsBIOLOGICAL

Human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group.

experimental group
human serum albuminOTHER

Saline solution containing 1 percent human serum albumin will be infused to the control group.

control group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • LVEF≤40％;
  • NYHA II-IV;
  • Received maximally tolerated guideline-directed medical therapy ( GDMT) for at least 3 months before enrollment;
  • Angiography or coronary CT within 6 months shows that there is no indication for PCI / CABG; Or PCI / CABG indications, but refused.

You may not qualify if:

  • Severe valvular heart disease, congenital heart disease, acute viral myocarditis and acute coronary syndrome.
  • PCI / CABG, ICD / permanent pacemaker / CRT implantation within 3 months.
  • Recent cerebrovascular disease (\<6 months).
  • eGFR\<30ml/min, or ALT/AST\>120U/L.
  • Hematologic disease: anemia (hemoglobin ≤9.0 g/dL); leukopenia (\<3500/μL); thrombocytopenia (\<70000/μL); myeloproliferative disorders, myelodysplastic syndrome, acute or chronic leukemia, and plasma cell dyscrasias (multiple myeloma, amyloidosis) .
  • Malignant tumor within 5 years.
  • Life expectancy \<1 year according any disease.
  • Uncontrolled acute infectious diseases.
  • Known or suspected of being sensitive to the study drugs or its ingredients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Failure Department, East Hospital Affiliated to Tongji University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Heart Failure, SystolicHeart Failure

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood Proteins

Study Officials

  • Zhongmin Liu, Doctor

    Shanghai East Hospital, Shanghai Tongji University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 13, 2021

First Posted

August 5, 2021

Study Start

July 28, 2021

Primary Completion

January 17, 2023

Study Completion

April 4, 2023

Last Updated

December 7, 2023

Record last verified: 2023-11

Locations

CN(1)