Alster Stem Cells - Intramyocardial Stem Therapy

Acute Myocardial Infarction Clinical Trial

Official title:

Percutaneous Intramyocardial Cell Therapy After Acute Myocardial Infarction Using Bone Marrow Mononuclear Cells

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00939042
• Other study ID #: 1777
• Secondary ID: 2008-004625-42
• Status: Terminated
• Phase: N/A
• Start date: January 2009
• Est. completion date: January 2014

Study information

• Verified date: October 2022
• Source: Asklepios proresearch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• LVDF < 45% after timely (max. 6 hours after the onset of symptomps) successful PCI
• conventional therapy according to the ESC guidelines for heart failure
• BMI > 20 and < 35

Exclusion Criteria:

• PCI elder then 21 days
• relevant valvular disease
• history of stroke/multivessel disease/thromboembolic event etc.
• DM Type I
• pregancy

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Early Left Ventricular Dysfunction
• Infarction
• Myocardial Infarction
• Ventricular Dysfunction
• Ventricular Dysfunction, Left

Intervention

Procedure:
• Percutaneous Coronary Intervention
common Percutaneous Coronary Intervention
• BMNC therapy
Injection of BMNC after common PCI

Locations

Country	Name	City	State
Germany	Asklepios Klinik St. Georg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Asklepios proresearch

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).		12 months
Secondary	Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.		12 months
Secondary	Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.		12 months