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Completed

NCT Number: NCT02635464

Human Umbilical Cord-derived Mesenchymal Stem Cells With Injectable Collagen Scaffold Transplantation for Chronic Ischemic Cardiomyopathy

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.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Glycated hemoglobin ≤6.5.

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.
  • 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.

Treatment and study plan

hUC-MSCs+Injectable collagen scaffold+CABG

Biological

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

Biological

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

Procedure

Patients underwent CABG alone.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Chinese Academy of Sciences

Other Gov

Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 18, 2015
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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