Trial | NCT03180450  Report issue

Title

The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)
The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Suspended

  • Study Participants

    60
The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients
This is a randomized, paralleled study. Patients will be divided into two groups of treatment and control. all of them will receive conventional treatment based on specific condition, including digitalis, milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), and antiplatelet aggregation etc. Treatment group patients will receive hUC-MSC. Follow-up visit will occur on 3 months, 6 months, and 12 months after the cell transfusion. Vital signs, blood routine test, urine routine test, liver function examination, etc, will be placed to evaluate the safety of hUC-MSC treatment. And the change of symptoms to evaluate the efficacy.
Study Started
Dec 31
2023
Anticipated
Primary Completion
Jun 30
2024
Anticipated
Study Completion
Dec 31
2024
Anticipated
Last Update
Apr 13
2023

Biological Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)

Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation.

Drug conventional treatment

The drug and usage will be determined based on patient's condition, including milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), or antiplatelet aggregation etc.

Treatment group Experimental

conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v.

Control group Placebo Comparator

Conventional treatment

Criteria 

Inclusion Criteria:

volunteer to participate in clinical trial, and sign informed consent form
with cardiac failure symptoms, including oppression in chest, breathe hard, lower limb edema. And new york heart association class as two to four
heart color ultrasound indicate left ventricular ejection fraction (LVEF) < 40%
content of serum NT-proBNP > 450pg/ml

Exclusion Criteria:

with severe drug allergy history or allergic constitution
patients were severe infected
with malignant tumor or with high tumor marker
with severe cardiorespiratory dysfunction, hematological system disease
with severe mental disorder, cognitive impairment
with persistent atrial fibrillation, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy or restrictive cardiomyopathy patients
end-stage renal insufficiency, pregnancy, or breast feeding women
bleeding tendency, active gastrointestinal ulcer
recent have major surgery, stroke, cancer, hepatic function insufficiency or other life-threatening condition.
under other therapy that possibly influence MSC security or efficacy
donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive
participant/donor: alcoholism, drug addicted, mental disease
No Results Posted