Clinical trial NCT03180450: The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)
Official title: The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
PHASE2
Conditions: Heart Failure
Keywords: Heart Failure
Human Umbilical Cord Mesenchymal Stem Cells
Lead sponsor: Sclnow Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Heart color ultrasound evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Single therapy effectiveness evaluation
timeFrame: 12 months
Other outcomes:
Locations:
city: Hohhot
country: China
facility: Inner Mongolia International Mongolian Hospital
state: Inner Mongolia
Study officials:
affiliation: Inner Mongolia International Mongolian Hospital
name: Nashundalai
role: STUDY_DIRECTOR
affiliation: China-Japan Union Hospital, Jilin University
name: Lei Guo, Dr.
role: STUDY_CHAIR
References: