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

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

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

Study Overview

• Status: Suspended
• Conditions: Heart Failure
• Intervention / Treatment: Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#); Drug: conventional treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China, 010065
      • Inner Mongolia International Mongolian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v.	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.
Placebo Comparator: Control group; Conventional treatment	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.

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

Collaborators and Investigators

• Sponsor: Sclnow Biotechnology Co., Ltd.
• Investigators: Study Chair: Lei Guo, Dr., China-Japan Union Hospital, Jilin University; Study Director: Nashundalai, Inner Mongolia International Mongolian Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 31, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (Actual): June 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Heart Failure; Human Umbilical Cord Mesenchymal Stem Cells
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: SCLnow-IMIMH-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No