Human Umbilical Cord-derived Mesenchymal Stem Cells With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy
NCT ID: NCT02635464
Last Updated: 2020-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2015-10-31
2019-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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hUC-MSCs+Injectable collagen scaffold+CABG
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.
hUC-MSCs+CABG
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.
CABG
CABG
Patients underwent CABG alone.
Interventions
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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.
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.
CABG
Patients underwent CABG alone.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. MRI confirmed that chronic coronary artery disease and ischemic regions.
4. Left ventricular ejection fraction (LVEF)≤40%.
5. NYHA Class II-IV.
6. No organ dysfunction for lung, liver and kidney.
7. Patients are able and willing to observe therapeutic effect and adverse events.
8. Signed informed consent.
9. Negative serum pregnancy test.
10. No coagulation dysfunction.
11. Glycated hemoglobin ≤6.5.
Exclusion Criteria
2. Ineligibility for CABG.
3. Unexplainable baseline laboratory abnormalities.
4. Sensitivity to any of the study medications.
5. Acute myocardial infarction within 1 months of enrollment in the study.
6. Patients suffering cardiovascular disease, such as aortic disease, malignant arrhythmias, congenital heart disease, intracardiac mass, moderate or severe valvular stenosis or regurgitation.
7. History of life threatening allergic or immune-mediated reaction.
8. Systemic infection or severe local infection.
9. Shock or MODS or patients cannot cooperate with doctors.
10. Severe heart, lung, liver or renal dysfunction.
11. Taking medicine that might have effect on outcomes assess.
12. Suffering HIV, Hepatitis B or Hepatitis C.
13. Participation in any clinical trial in recent three months.
14. History of mental illness or suicide risk.
15. High expectation or unrealistic demands.
16. Recently suffered a lot of radiation exposure.
17. Previous or current history of neoplasia or other comorbidity that could impact the patient's short-term survival.
18. 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).
19. Abnormal coagulation function.
20. Patients with hemodynamic instability which may lead to serious complications.
21. Any condition that, in the judgment of the investigator, would place the patient at under risk.
35 Years
65 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Chinese Academy of Sciences
OTHER_GOV
Responsible Party
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Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Principal Investigators
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Jianwu Dai, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Sciences
Locations
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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References
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He X, Wang Q, Zhao Y, Zhang H, Wang B, Pan J, Li J, Yu H, Wang L, Dai J, Wang D. Effect of Intramyocardial Grafting Collagen Scaffold With Mesenchymal Stromal Cells in Patients With Chronic Ischemic Heart Disease: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2016236. doi: 10.1001/jamanetworkopen.2020.16236.
Other Identifiers
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CAS-XDA-CIC/IGDB
Identifier Type: -
Identifier Source: org_study_id