The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)
- Conditions
- Heart Failure
- Interventions
- Drug: conventional treatmentBiological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
- Registration Number
- NCT03180450
- Lead Sponsor
- Sclnow Biotechnology Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group conventional treatment Conventional treatment Treatment group Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v. Treatment group conventional treatment conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Single therapy effectiveness evaluation 12 months Evaluate criteria:
* Recovery: symptoms disappear
* Excellent: symptoms improved obviously
* Efficient: symptoms improved
* Inefficient: symptoms no change or worse
Trial Locations
- Locations (1)
Inner Mongolia International Mongolian Hospital
🇨🇳Hohhot, Inner Mongolia, China