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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
Sponsor:
Information provided by (Responsible Party):
Shanghai East Hospital

Study Description
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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
Heart Failure, Systolic Biological: human umbilical cord mesenchymal stem cells Other: human serum albumin 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Albumins

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 12 month after treatment ]
    The comparison of the mortality between the two groups.

  2. NT-proBNP [ Time Frame: Day 7, Day 43, Day 91, Day 180, Day 360 ]
    The change in NT-proBNP after the infusion.

  3. 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

  4. 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.

  5. Minnesota Living with Heart Failure Questionnaire（MLHFQ） [ Time Frame: Day 43, Day 91, Day 180, Day 360 ]
    The change in MLHFQ after the infusion.

  6. PET/CMR [ Time Frame: Day 43, Day 180 ]
    The change in PET/CMR after the infusion


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Severe valvular heart disease, congenital heart disease, acute viral myocarditis and acute coronary syndrome.
  2. PCI / CABG, ICD / permanent pacemaker / CRT implantation within 3 months.
  3. Recent cerebrovascular disease (<6 months).
  4. eGFR<30ml/min, or ALT/AST>120U/L.
  5. 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) .
  6. Malignant tumor within 5 years.
  7. Life expectancy <1 year according any disease.
  8. Uncontrolled acute infectious diseases.
  9. Known or suspected of being sensitive to the study drugs or its ingredients.
  10. Not suitable for inclusion according to the evaluation of the sponsors or unwilling to comply with the study protocol.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Zhongmin Liu, Doctor +86-021-3880451 liu.zhongmin@tongji.edu.cn

Locations
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China, Shanghai
Heart Failure Department, East Hospital Affiliated to Tongji University Recruiting
Shanghai, Shanghai, China
Contact: Wei Han, Pro    +862138804518    dr.hanwei@foxmail.com   
Sponsors and Collaborators
Shanghai East Hospital
Investigators
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Principal Investigator: Zhongmin Liu, Doctor Shanghai East Hospital, Shanghai Tongji University
More Information
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Responsible Party: Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT04992832    
Other Study ID Numbers: DFSC-2018(CR)-08
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai East Hospital:
Human Umbilical Cord Mesenchymal Stem Cells
Heart Failure
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases