Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Heart Failure With Reduced Ejection Fraction PRIME-HFrEF Study

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    40
  • sponsor
    Shanghai East Hospital
Updated on 24 November 2021

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.

Description

The study was a 12-month single center, randomized, double-blind, placebo-controlled trial that included 12 weeks of treatment, and 9 months of follow-up.We plan to recruit 40 subjectswhich were divided into experimental group and control group. The volunteers of the experimental group will be given peripheral intravenously infusion a dose of 1.0*10^6/kg human umbilical cord mesenchymal stem cell (HUC-MSC) respectively at 0,6,12 week. The control group will be given the same dose of 1 percent human serum albumin injection. Then centralization visit was conducted at 0,7 day, 6,12 week, 6 and 12 month. The primary end points include cardiac function improvement and adverse events.

Details
Condition systolic heart failure
Treatment human serum albumin, Human umbilical cord mesenchymal stem cells
Clinical Study IdentifierNCT04992832
SponsorShanghai East Hospital
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

LVEF40
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

Exclusion Criteria

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/L); thrombocytopenia (<70000/L); 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
Not suitable for inclusion according to the evaluation of the sponsors or unwilling to comply with the study protocol
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