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

• ClinicalTrials.gov Identifier: NCT03180450
• Recruitment Status: Suspended
• First Posted: June 8, 2017
• Last Update Posted: October 28, 2020
• Sponsor: Sclnow Biotechnology Co., Ltd.
• Information provided by (Responsible Party): Sclnow Biotechnology Co., Ltd.

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

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 Design

• 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: October 2020
• Estimated Primary Completion Date: June 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

China, Inner Mongolia

Inner Mongolia International Mongolian Hospital

Hohhot, Inner Mongolia, China, 010065

Sponsors and Collaborators

Sclnow Biotechnology Co., Ltd.

Investigators

• Study Director: Nashundalai; Inner Mongolia International Mongolian Hospital
• Study Chair: Lei Guo, Dr.; China-Japan Union Hospital, Jilin University

More Information

• Responsible Party: Sclnow Biotechnology Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03180450
• Other Study ID Numbers: SCLnow-IMIMH-04
• First Posted: June 8, 2017
• Last Update Posted: October 28, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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