Heart Failure
Conditions
Keywords
Heart Failure, Human Umbilical Cord Mesenchymal Stem Cells
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.
Interventions
Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation.
DRUGconventional 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.
Sponsors
Sclnow Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart color ultrasound evaluation | 12 months | Criteria: * Excellent: ejection fraction improve to \> 50%; * Efficient: ejection fraction improved; * Inefficient: ejection fraction same as before treatment; * Exacerbation: ejection fraction declined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Single therapy effectiveness evaluation | 12 months | Evaluate criteria: * Recovery: symptoms disappear * Excellent: symptoms improved obviously * Efficient: symptoms improved * Inefficient: symptoms no change or worse |
Countries
China
Outcome results
None listed