Alster Stem Cells - Intramyocardial Stem Therapy

October 5, 2022 updated by: Asklepios proresearch

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Asklepios Klinik St. Georg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
PCI plus BNNC Therapy after acute myocardial infarction
Procedure: BMNC therapy
Injection of BMNC after common PCI
Active Comparator: 2
Percutaneous Coronary Intervention after acute myocardial infarction
Procedure: Percutaneous Coronary Intervention
common Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of the effect of a direct intramyocardial injection of bone marrow mononuclear cells (BMNC) on heart function (LVEF).
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of th eexplanatory power of echocardiography, endocardial left ventricular electromechanical mapping (LVEMM) with NOGA and cardiac MRI as an endpoint for myocardial regeneration.
Time Frame: 12 months
12 months
Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asklepios proresearch

Investigators

  • Principal Investigator: Karl-Heinz Kuck, MD, PhD, Asklepios Klinik St. Georg, Department of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

July 13, 2009

First Submitted That Met QC Criteria

July 13, 2009

First Posted (Estimate)

July 14, 2009

Study Record Updates

Last Update Posted (Actual)

October 6, 2022

Last Update Submitted That Met QC Criteria

October 5, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1777
  • 2008-004625-42 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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