Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy (UCMSC-Heart)

Affiliated Hospital to Academy of Military Medical Sciences

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Chronic Ischemic Heart Disease

Heart Failure

Angina

Treatments

Biological: UCMSC group

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02439541

307-IVY-SC-001

Details and patient eligibility

About

Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.

Full description

Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study.

Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention.

Every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects.

The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months.

Clinical results will be analyzed after completion of 12 months of followup.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 80 y
No option for PCI or CABG (Angiographies evaluated by an independent interventional cardiologist).
Maximal tolerable angina and heart failure medication
NYHA functional classification (I-III)
Signed informed consent

Exclusion criteria

Severe liver or renal dysfunction or hemorrhagic diseases not suitable for PCI.
Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month.
History with malignant disease within 5 y of inclusion or suspected malignity
Severe heart failure (NYHA functional classification IV)
Diminished functional capacity for other reasons such as COPD, alcoholic cardiomyopathy, or viral myocarditis
Clinical significant anemia, leukopenia, leukocytosis,or thrombocythemia
Clinical significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during treatment
Patients with reduced immune response or treated with immunosuppressive medication
Combined with severe infectious diseases
Pregnant or fertile women
Socially and mentally disabilities