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Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT01946048
Recruitment Status : Unknown
Verified October 2013 by Quanhai Li, Hebei Medical University.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2013
Last Update Posted : October 8, 2013
Sponsor:
Information provided by (Responsible Party):
Quanhai Li, Hebei Medical University

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 .

Condition or disease Intervention/treatment Phase
Ischemic Cardiomyopathy Biological: mesenchymal stem cells Phase 1

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  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Investigation of Patients With Ischemic Cardiomyopathy by Transplantation of Umbilical Cord Derived Mesenchymal Stem Cells
Study Start Date : October 2013
Estimated Primary Completion Date : October 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. all-cause mortality [ Time Frame: Post cell transplantation: one year ]
  2. all-cause morbidity [ Time Frame: Post cell transplantation: one year ]
  3. major adverse cardiac and cerebrovascular events [ Time Frame: Post cell transplantation: one year ]


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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946048


Locations
China, Hebei
the First Hospital of Hebei Medical University Active, not recruiting
Shijiazhuang, Hebei, China, 050000
Sponsors and Collaborators
Hebei Medical University
Investigators
Study Chair: Baoyong Yan, Doctor The First Hospital of Hebei Medical University
Study Director: Gang Liu, Doctor The First Hospital of Hebei Medical University
Principal Investigator: Guoping Ma, Master The First Hospital of Hebei Medical University
Principal Investigator: Jun Zhang, Master The First Hospital of Hebei Medical University

Responsible Party: Quanhai Li, Director of Cell Thearpy Center, the First Hospital of HeibeiMU, Hebei Medical University
ClinicalTrials.gov Identifier: NCT01946048     History of Changes
Other Study ID Numbers: 12276102D-Cardiac Disease
First Posted: September 19, 2013    Key Record Dates
Last Update Posted: October 8, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Ischemia
Cardiomyopathies
Pathologic Processes
Heart Diseases
Cardiovascular Diseases