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Heart Failure, SystolicPhase 1/2PRIME-HFrEFNCT04992832

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

A Phase 1/2 study testing human umbilical cord mesenchymal stem cells and human serum albumin in people with Heart Failure, Systolic, run by Shanghai East Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Heart Failure, Systolic
What is being tested?
human umbilical cord mesenchymal stem cells and human serum albumin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteChina
Study dates
28 Jul 2021to 4 Apr 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Heart Failure Department, East Hospital Affiliated to Tongji University

    Shanghai, Shanghai Municipality

Other trials in China

About this study

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

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.

Read the 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 safety end point is the incidence of any treatment emergent serious adverse events within12 months after intravenous MSC infusion, including death, nonfatal MI, stroke, sustained ventricular arrhythmias (>15 seconds or causing hemodynamic compromise), and other adverse events such as infection, tumor formation and clinical abnormal, which will be evaluated by monitoring for serial troponin, hematology, chemistry, urinalysis, 24-hour Holter, CTscans and ultrasound of abdomen.There are independent data and safety monitoring committees to monitor patient safety throughout the duration the trial.The primary efficacy endpoint is a change in Left Ventricular Ejection Fractions (LVEF) measured by left ventricular opacification (LVO) with contrast echocardiography and magnetic resonance imaging (MRI) at 12th month.

Being tested
human umbilical cord mesenchymal stem cells, human serum albumin
Keywords
Human Umbilical Cord Mesenchymal Stem Cells, Heart Failure
Medical subject headings
Heart Failure, Systolic, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • human umbilical cord mesenchymal stem cellsBiological

    Human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group.

  • human serum albuminOther

    Saline solution containing 1 percent human serum albumin will be infused to the control group.

Study groups in NCT04992832
Study groupRoleWhat they receive
experimental groupExperimentalThe 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.
Receives: Biological: human umbilical cord mesenchymal stem cells
control groupPlacebo comparatorThe control group will be given the same dose of saline containing human albumin.
Receives: Other: human serum albumin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The safety of treatment

    The incidence of treatment related adverse events

    Measured: Day 360

  2. Left ventricular ejection fraction

    The change in Left ventricular ejection fraction (LVEF) % after the infusion.

    Measured: Day 360

Secondary outcomes (8)

  1. A composite of cardiac death and rehospitalization caused by heart failure within 12 months

    The comparison of the mortality and the incidence of rehospitalization caused by heart failure between the two groups.

    Measured: 12 month after treatment

  2. NT-proBNP

    The change in NT-proBNP after the infusion.

    Measured: Day 360

  3. ST2

    The change in ST2 after the infusion.

    Measured: Day 360

  4. Left ventricular end systolic volume

    The change in Left ventricular end systolic volume(LVESV) after the infusion

    Measured: Day 43, Day 85, Day 180, Day 360

  5. 6 minutes walking distance

    The change in 6 minutes walking distance after the infusion.

    Measured: Day 360

  6. The SUV in PET-MR

    The change of standard uptake value in PET-MR after the infusion

    Measured: Day 180

  7. Right ventricular end systolic volume

    The change in Right ventricular end systolic volume(RVESV) after the infusion

    Measured: Day 360

  8. Tricuspid annular plane systolic excursion

    Changes of Right ventricular tricuspid annular plane systolic excursion (TAPSE) detected by echocardiography

    Measured: Day 360

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Aug 2021
  2. Study start28 Jul 2021
  3. Primary completion17 Jan 2023
  4. Study completion4 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04992832
Sponsor's protocol ID
DFSC-2018(CR)-08
Acronym
PRIME-HFrEF
Status last verified
Nov 2023
First submitted
13 Jul 2021
Last updated
7 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Han W, Jiao Y, Chen W, Gong X, Hu H, Xin Y, Guan S, Zhao J, Zhang Q, Yang B, Pan J, Wang H, Lu Q, Chu S, Cai D, Zheng L, Jia W, He Z, Yang H, Sun YE, Liu Z. PRIME-HFrEF Trial: a randomized, double-blind, multi-dose umbilical cord-derived mesenchymal stem cell regimen for heart failure. Signal Transduct Target Ther. 2026 Mar 26;11(1):112. doi: 10.1038/s41392-026-02678-5.

    PubMed 41888108

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing human umbilical cord mesenchymal stem cells and human serum albumin in people with Heart Failure, Systolic, run by Shanghai East Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The safety of treatment (time frame: Day 360). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04992832, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.

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