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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 : Recruiting
First Posted : December 18, 2015
Last Update Posted : February 15, 2018
Sponsor:
Collaborator:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Information provided by (Responsible Party):
Jianwu Dai, Chinese Academy of Sciences

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.

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)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy
Drug Information available for: Collagen

Arm Intervention/treatment
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 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.

Active Comparator: CABG Procedure: CABG
Patients underwent CABG alone.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Myocardial blood flow [ Time Frame: 1, 3, 6, 12 and 24 months ]
    Change in myocardial blood flow evaluated by Cardiac magnetic resonance imaging (MRI).

  2. 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).

  3. Infarct size [ Time Frame: 1, 3, 6, 12 and 24 months ]
    Change in infarct size evaluated by Cardiac magnetic resonance imaging (MRI).

  4. New York Heart Association (NYHA) Functional Classification [ Time Frame: 1, 3, 6, 12 and 24 months ]
    Change in clinical symptoms evaluated by NYHA.

  5. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Dongjin Wang, M.D. 86-25-83106666
Contact: Sufang Han, Ph.D. 86-10-82614420 sufanghan22@genetics.ac.cn

Locations
China, Jiangsu
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Recruiting
Nanjing, Jiangsu, China, 210008
Contact: Dongjin Wang, M.D.    86-25-83106666      
Contact: Qiang Wang    86-25-83106666 ext 60751    njuwangqiang@163.com   
Sponsors and Collaborators
Chinese Academy of Sciences
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigators
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
ClinicalTrials.gov Identifier: NCT02635464     History of Changes
Other Study ID Numbers: CAS-XDA-CIC/IGDB
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: December 2015

Additional relevant MeSH terms:
Ischemia
Cardiomyopathies
Pathologic Processes
Heart Diseases
Cardiovascular Diseases