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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03180450
• Other study ID #: SCLnow-IMIMH-04
• Status: Suspended
• Phase: Phase 1/Phase 2
• Start date: December 31, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Sclnow Biotechnology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Biological:
• Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation.

Drug:
• conventional 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.

Locations

Country	Name	City	State
China	Inner Mongolia International Mongolian Hospital	Hohhot	Inner Mongolia

Sponsors (1)

Lead Sponsor	Collaborator
Sclnow Biotechnology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Single therapy effectiveness evaluation	Evaluate criteria: Recovery: symptoms disappear; Excellent: symptoms improved obviously; Efficient: symptoms improved; Inefficient: symptoms no change or worse	12 months