Alster Stem Cells - Intramyocardial Stem Therapy

Not Applicable

Terminated

• Conditions: Acute Myocardial Infarction; Early Left Ventricular Dysfunction
• Interventions: Procedure: BMNC therapy; Procedure: Percutaneous Coronary Intervention

• Registration Number: NCT00939042
• Lead Sponsor: Asklepios proresearch

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-13
• Study First Posted: 2009-07-14
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BMNC therapy	PCI plus BNNC Therapy after acute myocardial infarction
2	Percutaneous Coronary Intervention	Percutaneous Coronary Intervention after acute myocardial infarction

Primary Outcome Measures

Name	Time	Method
Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).	12 months

Secondary Outcome Measures

Name	Time	Method
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
Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.	12 months

Trial Locations

Locations (1)

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany