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

Sponsor
Shanghai East Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04992832
Collaborator
(none)
40
1
2
29.1
1.4

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
  • 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

Study Type:
Interventional
Anticipated 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 :
Jul 28, 2021
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Primary Outcome Measures

  1. 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

  1. Mortality [12 month after treatment]

    The comparison of the mortality between the two groups.

  2. NT-proBNP [Day 7, Day 43, Day 91, Day 180, Day 360]

    The change in NT-proBNP after the infusion.

  3. 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

  4. 6 minutes walking distance [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) [Day 43, Day 91, Day 180, Day 360]

    The change in MLHFQ after the infusion.

  6. PET/CMR [Day 43, Day 180]

    The change in PET/CMR after the infusion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
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.
Responsible Party:
Shanghai East Hospital
ClinicalTrials.gov Identifier:
NCT04992832
Other Study ID Numbers:
  • DFSC-2018(CR)-08
First Posted:
Aug 5, 2021
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai East Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2021