Human Umbilical Cord-derived Mesenchymal Stem Cells With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy
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|ClinicalTrials.gov Identifier: NCT02635464|
Recruitment Status : Completed
First Posted : December 18, 2015
Last Update Posted : December 23, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Ischemic Cardiomyopathy||Biological: hUC-MSCs+Injectable collagen scaffold+CABG Biological: hUC-MSCs+CABG Procedure: CABG||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (hUC-MSCs) With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||August 2019|
|Actual Study Completion Date :||August 2019|
|Experimental: hUC-MSCs+Injectable collagen scaffold+CABG||
Biological: hUC-MSCs+Injectable collagen scaffold+CABG
Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) in collagen scaffold injecting in the infarct region.
|Active Comparator: hUC-MSCs+CABG||
Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) injecting in the infarct region.
|Active Comparator: CABG||
Patients underwent CABG alone.
- 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.
- Myocardial blood flow [ Time Frame: 1, 3, 6, 12 and 24 months ]Change in myocardial blood flow evaluated by Cardiac magnetic resonance imaging (MRI).
- Left ventricle ejection fraction (LVEF) [ Time Frame: 1, 3, 6, 12 and 24 months ]Change in LVEF as measured by ultrasonic cardiogram (UCG) and Cardiac magnetic resonance imaging (MRI).
- Infarct size [ Time Frame: 1, 3, 6, 12 and 24 months ]Change in infarct size evaluated by Cardiac magnetic resonance imaging (MRI).
- New York Heart Association (NYHA) Functional Classification [ Time Frame: 1, 3, 6, 12 and 24 months ]Change in clinical symptoms evaluated by NYHA.
- Canadian Cardiovascular Society (CCS) Angina Grading Scale [ Time Frame: 1, 3, 6, 12 and 24 months ]Change in clinical symptoms evaluated by CCS.
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|Ages Eligible for Study:||35 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Glycated hemoglobin ≤6.5.
- 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.
- Taking medicine that might have effect on outcomes assess.
- Suffering HIV, Hepatitis B or Hepatitis C.
- Participation in any clinical trial in recent three months.
- History of mental illness or suicide risk.
- High expectation or unrealistic demands.
- Recently suffered a lot of radiation exposure.
- Previous or current history of neoplasia or other comorbidity that could impact the patient's short-term survival.
- Patients with serious complications of coronary artery disease (e.g., perforation of interventricular septum and ventricular aneurysm and mitral regurgitation due to papillary muscle dysfunction).
- Abnormal coagulation function.
- Patients with hemodynamic instability which may lead to serious complications.
- Any condition that, in the judgment of the investigator, would place the patient at under risk.
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): NCT02635464
|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School|
|Nanjing, Jiangsu, China, 210008|
|Principal Investigator:||Jianwu Dai, Ph.D.||Chinese Academy of Sciences|
|Responsible Party:||Jianwu Dai, Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS, Chinese Academy of Sciences|
|Other Study ID Numbers:||
|First Posted:||December 18, 2015 Key Record Dates|
|Last Update Posted:||December 23, 2020|
|Last Verified:||December 2015|