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

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ClinicalTrials.gov Identifier: NCT03180450
Recruitment Status : Not yet recruiting
First Posted : June 8, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Sclnow Biotechnology Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Heart Failure Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) Drug: conventional treatment Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.




Primary Outcome Measures :
  1. Heart color ultrasound evaluation [ Time Frame: 12 months ]

    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 :
  1. Single therapy effectiveness evaluation [ Time Frame: 12 months ]

    Evaluate criteria:

    • Recovery: symptoms disappear
    • Excellent: symptoms improved obviously
    • Efficient: symptoms improved
    • Inefficient: symptoms no change or worse



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180450


Contacts
Contact: Lei Guo 861064368977 georgeguo@sclnow.com

Locations
China, Inner Mongolia
Inner Mongolia International Mongolian Hospital Not yet recruiting
Hohhot, Inner Mongolia, China, 010065
Contact: Bahushan    864715182094    bahushan@163.com   
Sponsors and Collaborators
Sclnow Biotechnology Co., Ltd.
Investigators
Study Director: Nashundalai Inner Mongolia International Mongolian Hospital
Study Chair: Lei Guo, Dr. Jilin University

Responsible Party: Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03180450     History of Changes
Other Study ID Numbers: SCLnow-IMIMH-04
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sclnow Biotechnology Co., Ltd.:
Heart Failure
Human Umbilical Cord Mesenchymal Stem Cells

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases