Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Ischemic Cardiomyopathy

Ischemic Cardiomyopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01946048
• Other study ID #: 12276102D-Cardiac Disease
• Status: Not yet recruiting
• Phase: Phase 1
• First received: September 12, 2013
• Last updated: October 5, 2013
• Start date: October 2013
• Est. completion date: December 2014

Study information

• Verified date: October 2013
• Source: Hebei Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Ischemia
• Ischemic Cardiomyopathy

Intervention

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.

Locations

Country	Name	City	State
China	the First Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Post cell transplantation: 1, 3, 6 months	No
Secondary	all-cause mortality		Post cell transplantation: one year	Yes
Secondary	all-cause morbidity		Post cell transplantation: one year	No
Secondary	major adverse cardiac and cerebrovascular events		Post cell transplantation: one year	No