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Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy

Primary Purpose

Ischemic Cardiomyopathy

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
mesenchymal stem cells
Sponsored by
Hebei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Cardiomyopathy

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the First Hospital of Hebei Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mesenchymal stem cells

Arm Description

Stem cells implantation Patients with severe coronary artery disease with ischemic cardiomyopathy managed with intramyocardial administration of allogeneic mesenchymal stem cells.

Outcomes

Primary Outcome Measures

The examination of heart function
Left ventricular ejection fraction： Change in left ventricular ejection fraction assessed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.

Secondary Outcome Measures

all-cause mortality
all-cause morbidity
major adverse cardiac and cerebrovascular events

Full Information

First Posted
September 12, 2013
Last Updated
October 5, 2013
Sponsor
Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01946048
Brief Title
Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy
Official Title
Safety and Efficacy Investigation of Patients With Ischemic Cardiomyopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebei Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 .
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Cardiomyopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mesenchymal stem cells
Arm Type
Experimental
Arm Description
Stem cells implantation Patients with severe coronary artery disease with ischemic cardiomyopathy managed with intramyocardial administration of allogeneic mesenchymal stem cells.
Intervention Type
Biological
Intervention Name(s)
mesenchymal stem cells
Intervention Description
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.
Primary Outcome Measure Information:
Title
The examination of heart function
Description
Left ventricular ejection fraction： Change in left ventricular ejection fraction assessed with echocardiography after intramyocardial implantation of allogeneic mesenchymal stem cells.
Time Frame
Post cell transplantation: 1, 3, 6 months
Secondary Outcome Measure Information:
Title
all-cause mortality
Time Frame
Post cell transplantation: one year
Title
all-cause morbidity
Time Frame
Post cell transplantation: one year
Title
major adverse cardiac and cerebrovascular events
Time Frame
Post cell transplantation: one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 30 to 80 years ischemic cardiomyopathy Left ventricular infarction area seriously low movement to no movement The low whole left ventricular systolic function (LVEF 45% or less) Have line or quasi coronary interventional treatment Willing to accept patients with follow-up evaluation Have signed informed consent form approved by the ethics committee Exclusion Criteria: Non elevation between S-wave and T-wave in patients with acute myocardial infarction No function damage in patients with acute myocardial infarction Acute myocardial infarction complicated with left ventricular aneurysm intends to do surgery Complications of acute myocardial infarction with other machines (including: ventricular septal perforation, papillary muscle rupture, etc.) Acute infectious diseases Blood system diseases, such as thrombocytopenia, severe anemia, leukemia, etc Severe renal disease, creatinine clearance < 36 ml/min, serum creatinine > 265 umol/L Laboratory tests suggest abnormal liver function, glutamate-pyruvate transaminase (ALT) > 4 times the upper limit of normal Unstable cerebral lesions malignant tumor Cognitive dysfunction and dementia patients, patients with severe mental illness Patients with severe physical disabilities can't regular follow-up Other serious uncontrolled system disease To prepare or have the pregnancy women patients Have a percutaneous coronary intervention contraindications: high-risk patients, such as the digestive tract, and intracranial hemorrhage or contrast allergy Cannot use the test dose atorvastatin 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) Patients unable or unwilling to sign a consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baoyong Yan, Doctor
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gang Liu, Doctor
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Guoping Ma, Master
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Zhang, Master
Organizational Affiliation
The First Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China

12. IPD Sharing Statement

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Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy

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