Alster Stem Cells - Intramyocardial Stem Therapy

NCT00939042 | Terminated

• 2 other identifiers: 17772008-004625-42
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Myocardial Infarction; Early Left Ventricular Dysfunction

Outcome Measures

Primary Outcomes (1)

• Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).

  12 months

Secondary Outcomes (2)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

PCI plus BNNC Therapy after acute myocardial infarction

Procedure: BMNC therapy

2

ACTIVE COMPARATOR

Percutaneous Coronary Intervention after acute myocardial infarction

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention PROCEDURE

common Percutaneous Coronary Intervention

2

BMNC therapy PROCEDURE

Injection of BMNC after common PCI

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Asklepios proresearch: lead

Study Sites (1)

Asklepios Klinik St. Georg

Hamburg, Germany

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Karl-Heinz Kuck, MD, PhD

  Asklepios Klinik St. Georg, Department of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 14, 2009
• Study Start: January 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 6, 2022

Record last verified: 2022-10

Locations

DE (1)