The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (hUC-MSCs) With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy

Chinese Academy of Sciences1 site in 1 country50 target enrollmentOctober 2015

ConditionsChronic Ischemic Cardiomyopathy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Ischemic Cardiomyopathy
Sponsor: Chinese Academy of Sciences
Enrollment: 50
Locations: 1
Primary Endpoint: Incidence of treatment-emergent adverse events
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The study is designed to assess the safety and efficacy of allogeneic human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) with injectable collagen scaffold transplanted into patients with chronic ischemic cardiomyopathy.

Registry

clinicaltrials.gov

Start Date

October 2015

End Date

August 2019

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chinese Academy of Sciences

Responsible Party

Principal Investigator

Jianwu Dai

Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS

Chinese Academy of Sciences

Eligibility Criteria

Inclusion Criteria

•Male or female, 35-65 years old.
•Chronic coronary artery disease with coronary Stenosis detectable by percutaneous coronary intervention (PCI). Ineligibility for percutaneous revascularization, as assessed by coronary arteriography. Ineligibility for percutaneous revascularization procedures was determined by 2 expert committees: a surgical committee comprising 2 cardiovascular surgeons and a noninvasive cardiologist, and an interventional committee comprising 2 interventional cardiologists and 1 noninvasive cardiologist.
•MRI confirmed that chronic coronary artery disease and ischemic regions.
•Left ventricular ejection fraction (LVEF)≤40%.
•NYHA Class II-IV.
•No organ dysfunction for lung, liver and kidney.
•Patients are able and willing to observe therapeutic effect and adverse events.
•Signed informed consent.
•Negative serum pregnancy test.
•No coagulation dysfunction.

Exclusion Criteria

•Lactating or pregnant woman.
•Ineligibility for CABG.
•Unexplainable baseline laboratory abnormalities.
•Sensitivity to any of the study medications.
•Acute myocardial infarction within 1 months of enrollment in the study.
•Patients suffering cardiovascular disease, such as aortic disease, malignant arrhythmias, congenital heart disease, intracardiac mass, moderate or severe valvular stenosis or regurgitation.
•History of life threatening allergic or immune-mediated reaction.
•Systemic infection or severe local infection.
•Shock or MODS or patients cannot cooperate with doctors.
•Severe heart, lung, liver or renal dysfunction.

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events

Time Frame: up to 24 months after surgery

Adverse events (AEs), serious adverse events (SAEs) and changes in vital signs, electrocardiogram (ECG) and laboratory values were measured.

Secondary Outcomes

Left ventricle ejection fraction (LVEF)(1, 3, 6, 12 and 24 months)
Infarct size(1, 3, 6, 12 and 24 months)
Myocardial blood flow(1, 3, 6, 12 and 24 months)
New York Heart Association (NYHA) Functional Classification(1, 3, 6, 12 and 24 months)
Canadian Cardiovascular Society (CCS) Angina Grading Scale(1, 3, 6, 12 and 24 months)