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

NCT ID: NCT03180450

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

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

Group Type EXPERIMENTAL

Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)

Intervention Type BIOLOGICAL

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

conventional treatment

Intervention Type 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

Conventional treatment

Group Type PLACEBO_COMPARATOR

conventional treatment

Intervention Type 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.

Interventions

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Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)

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

Intervention Type BIOLOGICAL

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sclnow Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nashundalai

Role: STUDY_DIRECTOR

Inner Mongolia International Mongolian Hospital

Lei Guo, Dr.

Role: STUDY_CHAIR

China-Japan Union Hospital, Jilin University

Locations

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Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, China

Site Status

Countries

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China

Other Identifiers

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SCLnow-IMIMH-04

Identifier Type: -

Identifier Source: org_study_id

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