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

December 21, 2020 updated by: Jianwu Dai, Chinese Academy of Sciences

The Safety and Efficacy Assessment of Human Umbilical Cord-derived Mesenchymal Stem Cells (hUC-MSCs) 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
up to 24 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Myocardial blood flow
Time Frame: 1, 3, 6, 12 and 24 months
Change in myocardial blood flow evaluated by Cardiac magnetic resonance imaging (MRI).
1, 3, 6, 12 and 24 months
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).
1, 3, 6, 12 and 24 months
Infarct size
Time Frame: 1, 3, 6, 12 and 24 months
Change in infarct size evaluated by Cardiac magnetic resonance imaging (MRI).
1, 3, 6, 12 and 24 months
New York Heart Association (NYHA) Functional Classification
Time Frame: 1, 3, 6, 12 and 24 months
Change in clinical symptoms evaluated by NYHA.
1, 3, 6, 12 and 24 months
Canadian Cardiovascular Society (CCS) Angina Grading Scale
Time Frame: 1, 3, 6, 12 and 24 months
Change in clinical symptoms evaluated by CCS.
1, 3, 6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese Academy of Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAS-XDA-CIC/IGDB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings