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

NCT03180450 | Suspended Phase 1

• 1 other identifier: SCLnow-IMIMH-04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Heart Failure

Keywords

Heart Failure; Human Umbilical Cord Mesenchymal Stem Cells

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Single therapy effectiveness evaluation

  12 months

Study Arms (2)

Treatment group

EXPERIMENTAL

conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v.

Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#); Drug: conventional treatment

Control group

PLACEBO COMPARATOR

Conventional treatment

Drug: conventional treatment

Interventions

Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) BIOLOGICAL

Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation.

Treatment group

conventional treatment DRUG

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.

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sclnow Biotechnology Co., Ltd.: lead

Study Sites (1)

Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, 010065, China

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Nashundalai

  Inner Mongolia International Mongolian Hospital

  STUDY DIRECTOR

• Lei Guo, Dr.

  China-Japan Union Hospital, Jilin University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: December 31, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)