Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Heart Failure With Reduced Ejection Fraction（PRIME-HFrEF Study） (PRIME-HFrEF)
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|ClinicalTrials.gov Identifier: NCT04992832|
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : December 12, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Systolic||Biological: human umbilical cord mesenchymal stem cells Other: human serum albumin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Actual Study Start Date :||July 28, 2021|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
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.
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.
- Left ventricular ejection fraction [ Time Frame: Day 7, Day 43, Day 91, Day 180, Day 360 ]The change in Left ventricular ejection fraction (LVEF) % after the infusion.
- Mortality [ Time Frame: 12 month after treatment ]The comparison of the mortality between the two groups.
- NT-proBNP [ Time Frame: Day 7, Day 43, Day 91, Day 180, Day 360 ]The change in NT-proBNP after the infusion.
- Left ventricular end diastolic diameter [ Time Frame: 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 [ Time Frame: 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） [ Time Frame: Day 43, Day 91, Day 180, Day 360 ]The change in MLHFQ after the infusion.
- PET/CMR [ Time Frame: Day 43, Day 180 ]The change in PET/CMR after the infusion
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|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04992832
|Contact: Zhongmin Liu, Doctorfirstname.lastname@example.org|
|Heart Failure Department, East Hospital Affiliated to Tongji University||Recruiting|
|Shanghai, Shanghai, China|
|Contact: Wei Han, Pro +862138804518 email@example.com|
|Principal Investigator:||Zhongmin Liu, Doctor||Shanghai East Hospital, Shanghai Tongji University|
|Responsible Party:||Shanghai East Hospital|
|Other Study ID Numbers:||
|First Posted:||August 5, 2021 Key Record Dates|
|Last Update Posted:||December 12, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Human Umbilical Cord Mesenchymal Stem Cells
Heart Failure, Systolic