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

Study Overview
=================
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.

Official Title
-----------------
The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
* Drug: conventional treatment


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v. | Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)<br>* Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation.<br>Drug: conventional treatment<br>* 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.<br>|
| Placebo Comparator: Control group<br>Conventional treatment | Drug: conventional treatment<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart color ultrasound evaluation | Criteria: Excellent: ejection fraction improve to > 50%; Efficient: ejection fraction improved; Inefficient: ejection fraction same as before treatment; Exacerbation: ejection fraction declined. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single therapy effectiveness evaluation | Evaluate criteria: Recovery: symptoms disappear Excellent: symptoms improved obviously Efficient: symptoms improved Inefficient: symptoms no change or worse | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Human Umbilical Cord Mesenchymal Stem Cells