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

Sclnow Biotechnology

Status and phase: Suspended; Phase 2; Phase 1

Conditions: Heart Failure

Treatments: Drug: conventional treatment; Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03180450

SCLnow-IMIMH-04

Details and patient eligibility

About

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

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

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

Treatment:

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

Drug: conventional treatment

Control group

Placebo Comparator group

Description:

Conventional treatment

Treatment:

Drug: conventional treatment