Back to resultsThe Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)
Primary Purpose
Heart Failure
Status
Suspended
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
conventional treatment
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Human Umbilical Cord Mesenchymal Stem Cells
Eligibility 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
Sites / Locations
- Inner Mongolia International Mongolian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment group
Control group
Arm Description
conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v.
Conventional treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Single therapy effectiveness evaluation
Evaluate criteria:
Recovery: symptoms disappear
Excellent: symptoms improved obviously
Efficient: symptoms improved
Inefficient: symptoms no change or worse
Full Information
NCT ID
NCT03180450
First Posted
June 6, 2017
Last Updated
April 11, 2023
Sponsor
Sclnow Biotechnology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03180450
Brief Title
The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)
Official Title
The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
Others
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sclnow Biotechnology Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Human Umbilical Cord Mesenchymal Stem Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Conventional treatment
Intervention Type
Biological
Intervention Name(s)
Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
Intervention Description
Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation.
Intervention Type
Drug
Intervention Name(s)
conventional treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Heart color ultrasound evaluation
Description
Criteria:
Excellent: ejection fraction improve to > 50%;
Efficient: ejection fraction improved;
Inefficient: ejection fraction same as before treatment;
Exacerbation: ejection fraction declined.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Single therapy effectiveness evaluation
Description
Evaluate criteria:
Recovery: symptoms disappear
Excellent: symptoms improved obviously
Efficient: symptoms improved
Inefficient: symptoms no change or worse
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nashundalai
Organizational Affiliation
Inner Mongolia International Mongolian Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lei Guo, Dr.
Organizational Affiliation
China-Japan Union Hospital, Jilin University
Official's Role
Study Chair
Facility Information:
Facility Name
Inner Mongolia International Mongolian Hospital
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010065
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-HF)
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