The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
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ClinicalTrials.gov Identifier: NCT03180450 |
Recruitment Status :
Suspended
(Others)
First Posted : June 8, 2017
Last Update Posted : October 28, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Heart Failure | Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) Drug: conventional treatment | Phase 1 Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment group
conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v.
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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
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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. |
- 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.
- 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 |
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

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
China, Inner Mongolia | |
Inner Mongolia International Mongolian Hospital | |
Hohhot, Inner Mongolia, China, 010065 |
Study Director: | Nashundalai | Inner Mongolia International Mongolian Hospital | |
Study Chair: | Lei Guo, Dr. | China-Japan Union Hospital, Jilin University |
Responsible Party: | Sclnow Biotechnology Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03180450 |
Other Study ID Numbers: |
SCLnow-IMIMH-04 |
First Posted: | June 8, 2017 Key Record Dates |
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 |
Heart Failure Human Umbilical Cord Mesenchymal Stem Cells |
Heart Failure Heart Diseases Cardiovascular Diseases |