Angina, Chronic Ischemic Heart Disease, Heart Failure
Conditions
Keywords
cellular therapy, Chronic ischemic heart disease, phase 1/2 clinical study, human umbilical cord mesenchymal stem cell, ischemic heart disease, allogeneic stem cell transplantation
Brief summary
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.
Detailed 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.
Interventions
BIOLOGICALUCMSC group
Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10\^7)
Sponsors
Ivy Institute of Stem Cells Co. Ltd
Affiliated Hospital to Academy of Military Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number and nature of adverse events | Within the first year after intracoronary infusion | Evidence for new clinical/biological abnormalities. |
| Incidence of major adverse coronary events (MACE) | Within the first year after intracoronary infusion | Major adverse coronary events (MACE) were defined as cardiac death, non-fatal myocardial infarction, or rehospitalization for acute coronary syndrome and for congestive heart failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Time and Level | Post cell transplantation: 1, 3, 6, 12 months | Exercise time and level as assessed via six minute walk test. |
| Quantify myocardium perfusion measured by SPECT | Post cell transplantation: 6, 12 months | The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 6 and 12 months in perfusion images, as measured by SPECT. |
| Assessment of heart function by left ventricular ejection fraction | Post cell transplantation: 1, 3, 6，12 months | Change in left ventricular ejection fraction was assessed with echocardiography after cell implantation. |
| Clinical Improvement in NYHA Classification | 1 year | The NYHA scale ranges from 1 (best)Mild- no limitation of physical activity due to heart failure to 4 (worst) Severe-Unable to carry out any physical activity without discomfort due to heart failure. |
Countries
China
Contacts
Primary ContactXiaozhong Zhang, M.D
Outcome results
None listed