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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 : Unknown
Verified December 2015 by Jianwu Dai, Chinese Academy of Sciences.
Recruitment status was:  Active, not recruiting
First Posted : December 18, 2015
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

Tracking Information
First Submitted Date  ICMJE December 13, 2015
First Posted Date  ICMJE December 18, 2015
Last Update Posted Date January 7, 2019
Study Start Date  ICMJE October 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Human Umbilical Cord-derived Mesenchymal Stem Cells With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy
Official Title  ICMJE The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (hUC-MSCs) With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Ischemic Cardiomyopathy
Intervention  ICMJE
  • 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.
  • Biological: 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.
  • Procedure: CABG
    Patients underwent CABG alone.
Study Arms  ICMJE
  • Experimental: hUC-MSCs+Injectable collagen scaffold+CABG
    Intervention: Biological: hUC-MSCs+Injectable collagen scaffold+CABG
  • Active Comparator: hUC-MSCs+CABG
    Intervention: Biological: hUC-MSCs+CABG
  • Active Comparator: CABG
    Intervention: Procedure: CABG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 16, 2015)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, 35-65 years old.
  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:

  1. Lactating or pregnant woman.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02635464
Other Study ID Numbers  ICMJE CAS-XDA-CIC/IGDB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jianwu Dai, Chinese Academy of Sciences
Study Sponsor  ICMJE Chinese Academy of Sciences
Collaborators  ICMJE The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators  ICMJE
Principal Investigator: Jianwu Dai, Ph.D. Chinese Academy of Sciences
PRS Account Chinese Academy of Sciences
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP