Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy (UCMSC-Heart)

March 14, 2016 updated by: Affiliated Hospital to Academy of Military Medical Sciences

Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Ischemic Cardiomyopathy

Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study.

Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention.

Every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects.

The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months.

Clinical results will be analyzed after completion of 12 months of followup.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • 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
      • Beijing, China, 100071
        • Recruiting
        • Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences
        • Contact:

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

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 80 y
  • No option for PCI or CABG (Angiographies evaluated by an independent interventional cardiologist).
  • Maximal tolerable angina and heart failure medication
  • NYHA functional classification (I-III)
  • Signed informed consent

Exclusion Criteria:

  • Severe liver or renal dysfunction or hemorrhagic diseases not suitable for PCI.
  • Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month.
  • History with malignant disease within 5 y of inclusion or suspected malignity
  • Severe heart failure (NYHA functional classification IV)
  • Diminished functional capacity for other reasons such as COPD, alcoholic cardiomyopathy, or viral myocarditis
  • Clinical significant anemia, leukopenia, leukocytosis,or thrombocythemia
  • Clinical significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during treatment
  • Patients with reduced immune response or treated with immunosuppressive medication
  • Combined with severe infectious diseases
  • Pregnant or fertile women
  • Socially and mentally disabilities

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UCMSC group
Patients in this arm received umbilical cord MSCs by intracoronary injection
Biological: UCMSC group
Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10^7)
No Intervention: Control group
Patients in this arm did not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and nature of adverse events
Time Frame: Within the first year after intracoronary infusion
Evidence for new clinical/biological abnormalities.
Within the first year after intracoronary infusion
Incidence of major adverse coronary events (MACE)
Time Frame: Within the first year after intracoronary infusion
Major adverse coronary events (MACE) were defined as cardiac death, non-fatal myocardial infarction, or rehospitalization for acute coronary syndrome and for congestive heart failure.
Within the first year after intracoronary infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Time and Level
Time Frame: Post cell transplantation: 1, 3, 6, 12 months
Exercise time and level as assessed via six minute walk test.
Post cell transplantation: 1, 3, 6, 12 months
Quantify myocardium perfusion measured by SPECT
Time Frame: Post cell transplantation: 6, 12 months
The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 6 and 12 months in perfusion images, as measured by SPECT.
Post cell transplantation: 6, 12 months
Assessment of heart function by left ventricular ejection fraction
Time Frame: Post cell transplantation: 1, 3, 6，12 months
Change in left ventricular ejection fraction was assessed with echocardiography after cell implantation.
Post cell transplantation: 1, 3, 6，12 months
Clinical Improvement in NYHA Classification
Time Frame: 1 year
The NYHA scale ranges from 1 (best)"Mild- no limitation of physical activity due to heart failure" to 4 (worst) "Severe-Unable to carry out any physical activity without discomfort due to heart failure".
1 year

Collaborators and Investigators

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

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Collaborators

Ivy Institute of Stem Cells Co. Ltd

Investigators

  • Study Chair: Bing Liu, M.D, 307-IVY Translational Medicine Center
  • Principal Investigator: Xiaozhong Zhang, M.D, Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences

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

May 1, 2015

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

May 5, 2015

First Submitted That Met QC Criteria

May 7, 2015

First Posted (Estimate)

May 8, 2015

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 307-IVY-SC-001

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.

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