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

• Status: Suspended
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sclnow Biotechnology Co., Ltd.
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Enzyme Inhibitors

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