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Clinical study of human umbilical cord mesenchymal stem cells (HUC-MSCs) on heart failure with reduced ejection fraction (HFrEF)

Clinical study of human umbilical cord mesenchymal stem cells (HUC-MSCs) on heart failure with reduced ejection fraction (HFrEF)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040778
Enrollment
Unknown
Registered
2020-12-10
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure with reduced ejection fraction

Interventions

control:Common drug therapy
HUC-MSCs therapy:common durg and HUM-MSCs iv injection
HUC-MSCs and chinese medicine therapy:common durg, HUM-MSCs iv injection and classic chinese medicine combined thearpy
chinese medicine therapy:common durg and classic chinese medicine

Sponsors

Shanghai Oriental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Subjects must meet all of the following inclusion criteria to be included in this study: 1) Aged 18-80 years old at the time of signing the informed consent form; 2) Patients with HErEF, left ventricular ejection fraction (LVEF) =200 pg/mL or N-terminal forebrain natriuretic peptide (NT-proBNP) >=2000 pg/mL 2 weeks before enrollment; 6) Able to understand the research process and methods, voluntarily participate in and strictly abide by the clinical research, the subjects themselves voluntarily participate and sign the informed consent in writing.

Exclusion criteria

Exclusion criteria: Subjects with any of the following cannot be included in this study. 1) People with the following diseases, including valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, congenital heart disease, acute viral myocarditis, acute coronary syndrome and severe liver and kidney dysfunction; 2) People with allergies or previous history of biological drug allergy; 3) Those who are in pregnancy or lactation; 4) HIV, HCV positive; HBV-DNA>=1x10^3 copies/mL (or 2x10^2 IU/mL); acute Treponema pallidum infection; 5) Blood biochemical examination shows that serum urea nitrogen, creatinine, and transaminase are more than 3 times the upper limit of normal; 6) People suffering from any infectious diseases (including bacterial and viral infections); 7) Ischemic heart failure without revascularization or less than 6 months after revascularization; 8) Patients with acute pulmonary edema or acute hemodynamic disturbance; 9) People with right heart failure due to lung disease; 10) Patients with persistent ventricular tachycardia and ventricular tachycardia whose antiarrhythmic drugs are ineffective; 11) Those who have participated in any drug clinical trials within 3 months before enrollment; 12) Those who had a pacemaker implanted within 3 months before enrollment; 13) Those who have had a stroke within 6 months before enrollment; 14) Severe neurological diseases (Alzheimer's disease, advanced Parkinson's syndrome), lower extremities or deaf-mute patients; 15) Those who have a history of tumors or are currently suffering from tumors, or those who have precancerous lesions confirmed by pathological examination (such as ductal carcinoma in situ of the breast, or cervical dysplasia); 16) Patients with blood diseases: anemia (hemoglobin <=9.5g/dL); leukopenia (<4000/uL); thrombocytopenia (<75000/µL); myeloproliferative diseases, such as acute or chronic leukemia, plasma cell disease ( Multiple myeloma, amyloidosis), etc.; 17) Through examination (physical examination, or X-ray examination or B-ultrasound examination or other means), patients with endocrine activity, hyperplastic glands or adenomas that affect heart function or endocrine function, such as pheochromocytoma, thyroid gland Enlargement; or other endocrine diseases; 18) According to the researcher's assessment, those who believe that the subject is unable or unwilling to comply with the requirements of the research protocol.

Design outcomes

Primary

MeasureTime frame
cardiac function evaluated by echocardiography;

Secondary

MeasureTime frame
NT-proBNP level;6-minute walk test;NYHA Heart Function Assessment;

Countries

China

Contacts

Public ContactZhongming Liu

Shanghai Oriental Hospital

zhm@tongji.edu.cn+86 1896453899

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026