Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Heart Failure With Reduced Ejection Fraction(PRIME-HFrEF Study)
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1/Phase 2 |
Detailed 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 subjects,which 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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: experimental group 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
Human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group.
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Placebo Comparator: control group The control group will be given the same dose of saline containing human albumin. |
Other: human serum albumin
Saline solution containing 1 percent human serum albumin will be infused to the control group.
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Outcome Measures
Primary Outcome Measures
- Left ventricular ejection fraction [Day 7, Day 43, Day 91, Day 180, Day 360]
The change in Left ventricular ejection fraction (LVEF) % after the infusion.
Secondary Outcome Measures
- Mortality [12 month after treatment]
The comparison of the mortality between the two groups.
- NT-proBNP [Day 7, Day 43, Day 91, Day 180, Day 360]
The change in NT-proBNP after the infusion.
- Left ventricular end diastolic diameter [Day 7, Day 43, Day 91, Day 180, Day 360]
The change in Left ventricular end diastolic diameter(LVEDD) after the infusion
- 6 minutes walking distance [Day 7, Day 43, Day 91, Day 180, Day 360]
The change in 6 minutes walking distance after the infusion.
- Minnesota Living with Heart Failure Questionnaire(MLHFQ) [Day 43, Day 91, Day 180, Day 360]
The change in MLHFQ after the infusion.
- PET/CMR [Day 43, Day 180]
The change in PET/CMR after the infusion
Eligibility Criteria
Criteria
Inclusion Criteria:
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LVEF≤40%;
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NYHA II-IV;
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Received maximally tolerated guideline-directed medical therapy ( GDMT) for at least 3 months before enrollment;
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Angiography or coronary CT within 6 months shows that there is no indication for PCI / CABG; Or PCI / CABG indications, but refused.
Exclusion Criteria:
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Severe valvular heart disease, congenital heart disease, acute viral myocarditis and acute coronary syndrome.
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PCI / CABG, ICD / permanent pacemaker / CRT implantation within 3 months.
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Recent cerebrovascular disease (<6 months).
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eGFR<30ml/min, or ALT/AST>120U/L.
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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) .
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Malignant tumor within 5 years.
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Life expectancy <1 year according any disease.
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Uncontrolled acute infectious diseases.
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Known or suspected of being sensitive to the study drugs or its ingredients.
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Not suitable for inclusion according to the evaluation of the sponsors or unwilling to comply with the study protocol.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Heart Failure Department, East Hospital Affiliated to Tongji University | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Shanghai East Hospital
Investigators
- Principal Investigator: Zhongmin Liu, Doctor, Shanghai East Hospital, Shanghai Tongji University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DFSC-2018(CR)-08