Alster Stem Cells - Intramyocardial Stem Therapy

Asklepios proresearch

Status: Terminated

Conditions: Early Left Ventricular Dysfunction; Acute Myocardial Infarction

Treatments: Procedure: Percutaneous Coronary Intervention; Procedure: BMNC therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT00939042

1777

2008-004625-42

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Active Comparator group

Description:

PCI plus BNNC Therapy after acute myocardial infarction

Treatment:

Procedure: BMNC therapy

2

Active Comparator group

Description:

Percutaneous Coronary Intervention after acute myocardial infarction

Treatment:

Procedure: Percutaneous Coronary Intervention