Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy

• ClinicalTrials.gov Identifier: NCT01946048
• Recruitment Status: Unknown
• First Posted: September 19, 2013
• Last Update Posted: October 8, 2013
• Sponsor: Hebei Medical University
• Information provided by (Responsible Party): Quanhai Li, Hebei Medical University

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 .

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• 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

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

China, Hebei

the First Hospital of Hebei Medical University

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

More Information

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

Additional relevant MeSH terms:

Cardiomyopathies; Ischemia; Pathologic Processes; Heart Diseases; Cardiovascular Diseases