Back to resultsMulti-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Heart Failure With Reduced Ejection Fraction（PRIME-HFrEF Study） (PRIME-HFrEF)
Primary Purpose
Heart Failure, Systolic
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
human umbilical cord mesenchymal stem cells
human serum albumin
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Human Umbilical Cord Mesenchymal Stem Cells, Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 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.
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/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.
- Not suitable for inclusion according to the evaluation of the sponsors or unwilling to comply with the study protocol.
Sites / Locations
- Heart Failure Department, East Hospital Affiliated to Tongji University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
experimental group
control group
Arm Description
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.
The control group will be given the same dose of saline containing human albumin.
Outcomes
Primary Outcome Measures
Left ventricular ejection fraction
The change in Left ventricular ejection fraction (LVEF) % after the infusion.
Secondary Outcome Measures
Mortality
The comparison of the mortality between the two groups.
NT-proBNP
The change in NT-proBNP after the infusion.
Left ventricular end diastolic diameter
The change in Left ventricular end diastolic diameter(LVEDD) after the infusion
6 minutes walking distance
The change in 6 minutes walking distance after the infusion.
Minnesota Living with Heart Failure Questionnaire（MLHFQ）
The change in MLHFQ after the infusion.
PET/CMR
The change in PET/CMR after the infusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04992832
Brief Title
Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Heart Failure With Reduced Ejection Fraction（PRIME-HFrEF Study）
Acronym
PRIME-HFrEF
Official Title
Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells for Treatment in Heart Failure Patients With Reduced Ejection Fraction: A Randomized, Double Blind, Placebo-Controlled, Prospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
January 17, 2023 (Actual)
Study Completion Date
April 4, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Systolic
Keywords
Human Umbilical Cord Mesenchymal Stem Cells, Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The control group will be given the same dose of saline containing human albumin.
Intervention Type
Biological
Intervention Name(s)
human umbilical cord mesenchymal stem cells
Intervention Description
Human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group.
Intervention Type
Other
Intervention Name(s)
human serum albumin
Intervention Description
Saline solution containing 1 percent human serum albumin will be infused to the control group.
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Description
The change in Left ventricular ejection fraction (LVEF) % after the infusion.
Time Frame
Day 7, Day 43, Day 91, Day 180, Day 360
Secondary Outcome Measure Information:
Title
Mortality
Description
The comparison of the mortality between the two groups.
Time Frame
12 month after treatment
Title
NT-proBNP
Description
The change in NT-proBNP after the infusion.
Time Frame
Day 7, Day 43, Day 91, Day 180, Day 360
Title
Left ventricular end diastolic diameter
Description
The change in Left ventricular end diastolic diameter(LVEDD) after the infusion
Time Frame
Day 7, Day 43, Day 91, Day 180, Day 360
Title
6 minutes walking distance
Description
The change in 6 minutes walking distance after the infusion.
Time Frame
Day 7, Day 43, Day 91, Day 180, Day 360
Title
Minnesota Living with Heart Failure Questionnaire（MLHFQ）
Description
The change in MLHFQ after the infusion.
Time Frame
Day 43, Day 91, Day 180, Day 360
Title
PET/CMR
Description
The change in PET/CMR after the infusion
Time Frame
Day 43, Day 180
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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/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.
Not suitable for inclusion according to the evaluation of the sponsors or unwilling to comply with the study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhongmin Liu, Doctor
Organizational Affiliation
Shanghai East Hospital, Shanghai Tongji University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Failure Department, East Hospital Affiliated to Tongji University
City
Shanghai
State/Province
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Heart Failure With Reduced Ejection Fraction（PRIME-HFrEF Study）
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