Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy

October 5, 2013 updated by: Quanhai Li, Hebei Medical University

Safety and Efficacy Investigation of Patients With Ischemic Cardiomyopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells

The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Coronary artery disease (CAD) is a common disorder that can lead to heart failure. Not all people with CAD are eligible for today's standard treatments. One new treatment approach uses umbilical cord blood derived mesenchymal stem cells-specialized cells capable of developing into other types of cells-to stimulate growth of new blood vessels for the heart. The aim of the present study is to investigate safety and efficacy of intramyocardial implantation of allogeneic mesenchymal stem cells in patients with ischemic cardiomyopathy .

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • 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
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • The First Hospital of Hebei Medical University

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

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age from 30 to 80 years
  2. ischemic cardiomyopathy
  3. Left ventricular infarction area seriously low movement to no movement
  4. The low whole left ventricular systolic function (LVEF 45% or less)
  5. Have line or quasi coronary interventional treatment
  6. Willing to accept patients with follow-up evaluation
  7. Have signed informed consent form approved by the ethics committee

Exclusion Criteria:

  1. Non elevation between S-wave and T-wave in patients with acute myocardial infarction
  2. No function damage in patients with acute myocardial infarction
  3. Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery
  4. Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.)
  5. Acute infectious diseases
  6. Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc
  7. Severe renal disease, creatinine clearance < 36 ml/min, serum creatinine > 265 umol/L
  8. Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) > 4 times the upper limit of normal
  9. Unstable cerebral lesions
  10. malignant tumor
  11. Cognitive dysfunction and dementia patients, patients with severe mental illness
  12. Patients with severe physical disabilities can't regular follow-up
  13. Other serious uncontrolled system disease
  14. To prepare or have the pregnancy women patients
  15. Have a percutaneous coronary intervention contraindications: high-risk patients, such as the digestive tract, and intracranial hemorrhage or contrast allergy
  16. Cannot use the test dose atorvastatin
  17. Is not completed in accordance with the requirements for test the timing of the magnetic resonance imaging (MRI), PET, SPECT, follow-up testing (e.g., patients with implanted pacemakers or artificial joint)
  18. Patients unable or unwilling to sign a consent form

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mesenchymal stem cells
Stem cells implantation Patients with severe coronary artery disease with ischemic cardiomyopathy managed with intramyocardial administration of allogeneic mesenchymal stem cells.
Biological: mesenchymal stem cells

Procedure: Selected patients were randomly divided into a cell therapy group and a control group.

Umbilical Cord Blood Derived Mesenchymal Stem Cells at a dose of 150-250 million.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The examination of heart function
Time Frame: Post cell transplantation: 1, 3, 6 months
Left ventricular ejection fraction： Change in left ventricular ejection fraction assessed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.
Post cell transplantation: 1, 3, 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
all-cause mortality
Time Frame: Post cell transplantation: one year
Post cell transplantation: one year
all-cause morbidity
Time Frame: Post cell transplantation: one year
Post cell transplantation: one year
major adverse cardiac and cerebrovascular events
Time Frame: Post cell transplantation: one year
Post cell transplantation: one year

Collaborators and Investigators

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

Sponsor

Hebei Medical University

Investigators

  • Study Director: Gang Liu, Doctor, The First Hospital of Hebei Medical University
  • Principal Investigator: Guoping Ma, Master, The First Hospital of Hebei Medical University

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

October 1, 2013

Primary Completion (Anticipated)

October 1, 2013

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

September 12, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (Estimate)

September 19, 2013

Study Record Updates

Last Update Posted (Estimate)

October 8, 2013

Last Update Submitted That Met QC Criteria

October 5, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12276102D-Cardiac Disease

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.

Clinical Trials on Ischemic Cardiomyopathy

Clinical Trials on mesenchymal stem cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe