Intra-coronary Versus Intramyocardial Application of Enriched CD133pos Autologous Bone Marrow Derived Stem Cells (AlsterMACS)

This study is currently recruiting participants.
Verified August 2012 by Asklepios proresearch
Sponsor:
Collaborator:
Miltenyi Biotec GmbH
Information provided by:
Asklepios proresearch
ClinicalTrials.gov Identifier:
NCT01337011
First received: April 14, 2011
Last updated: August 10, 2012
Last verified: August 2012
  Purpose

This is a pilot study comparing the effect of intra-coronary versus intramyocardial application of enriched CD133pos autologous bone marrow derived stem cells for improving left ventricular function in chronic ischemic cardiomyopathy.


Condition Intervention Phase
Heart Failure
Other: autologous CD133pos stem cell application
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pilot Study Comparing the Effect of Intra-coronary Versus Intramyocardial Application of Enriched CD133pos Autologous Bone Marrow Derived Stem Cells for Improving Left Ventricular Function in Chronic Ischemic Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Asklepios proresearch:

Primary Outcome Measures:
  • Change in Left Ventricular Global Ejection Fraction measured via echocardiography [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    In patients with chronic ischemic cardiomyopathy and a LVEF ≤45% and NYHA >_ II despite optimal therapy, the application of CD133pos cells isolated from bone marrow aspirate via the intra-coronary route as well as via NOGA-guided intra-myocardial cell delivery system leads to a significant improvement in left ventricular global ejection fraction measured via echocardiography compared to baseline at 6 months.


Secondary Outcome Measures:
  • The application of CD133pos cells into the coronary system or intra-myocardial via the NOGA system is safe and feasible; the route of application of CD133pos cells has no effect on MACCE [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The application of CD133pos cells into the coronary system or intra-myocardial via the NOGA system is safe and feasible; the route of application of CD133pos cells has no effect on MACCE (stroke, infarct, death).

  • Decrease of brain natriuretic peptide [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    The application of CD133pos cells intra-myocardial via the NOGA system and delivery of the cells via the coronary system has a significant effect concerning decrease of brain natriuretic peptide after 6 and 12 months compared to baseline. Significant effect is defined by a relative decrease of 10 % compared to the measured value at baseline.

  • Improvement of 6 min walk [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    The application of CD133pos cells intra-myocardial via the NOGA system and delivery of the cells via the coronary system has a significant effect concerning improvement of 6 min walk test after 6 and 12 months compared to baseline. Significant improvement is defined by a relative increase of 10 % compared to the measured value at baseline.

  • Improvement of peak oxygen consumption [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    The application of CD133pos cells intra-myocardial via the NOGA system and delivery of the cells via the coronary system has a significant effect concerning improvement of peak oxygen consumption after 6 and 12 months compared to baseline. Significant improvement is defined by a relative increase of 10 % compared to the measured value at baseline.

  • The application of CD133pos cells intra-myocardial is equally effective to the intracoronary application route regarding LV function [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    The application of CD133pos cells intra-myocardial via the NOGA system is equally effective to the intracoronary application route regarding LV function as measured by cardiac MRI, a decrease in BNP, an increase in 6min walk test and an increase in peak oxygen consumption.

  • Improvement of LV function as measured by cardiacMRI [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    The application of CD133pos cells intra-myocardial via the NOGA system and intra-coronary leads to a significant improvement of LV function as measured by cardiacMRI at 6 and 12 months compared to baseline in patients with no contra-indications for MRI (i.e. ICD or CRT). Significant improvement is defined by an absolute increase of LVEF of 5%.


Estimated Enrollment: 64
Study Start Date: July 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intra-coronary administration Other: autologous CD133pos stem cell application
The study aims to show efficacy of both intra-myocardial autologous CD133pos bone marrow cell application as well as intra-coronary CD133pos cell application in patients with symptomatic ischemic heart disease. In addition, efficacy between the two delivery routes will be compared.
Experimental: intra-myocardial administration Other: autologous CD133pos stem cell application
The study aims to show efficacy of both intra-myocardial autologous CD133pos bone marrow cell application as well as intra-coronary CD133pos cell application in patients with symptomatic ischemic heart disease. In addition, efficacy between the two delivery routes will be compared.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 to 80 years old
  • Of female and male gender
  • Patient has reduced ejection fraction as evaluated by routine clinical angiogram, echocardiography or MRI (≤45%) due to ischemic heart disease
  • symptomatic heart failure NYHA ≥ II on optimal therapy
  • coronary artery in the target region that can be used for cell infusion
  • Patient has been informed of the nature of the clinical trial and agrees to its provision and has provided written informed consent

Exclusion Criteria:

  • planned or performed CABG surgery or PCI within 4 weeks of study entry
  • recent myocardial infarction (< 6 months)
  • TIMI flow < II in the coronary artery selected for infusion
  • cardiogenic shock requiring mechanical ventilation or intra-aortic balloon pump
  • progressive tumor disease
  • primary disease of bone marrow including mal-function of components of the coagulation system
  • women of child-bearing age premenopausal
  • LV wall thickness < 5mm at planned site of injection
  • ventricular wall thrombus
  • severe aortic valvular heart disease
  • severe atrial or ventricular tachycardia unresponsive to intravenous or oral drug therapy
  • aneurysm of the anterior wall
  • history of stroke
  • know diseases of the liver resulting in reduced plasmatic coagulation with spontaneous INR >2
  • patients with chronic infectious diseases (HBV, HCV, HIV, seropositivity for Treponema pallidum)
  • patients taking part or have taken part in other clinical trials within the past 3 months
  • patients unable to provide informed consent
  • any other medical condition that the enrolling physician deems significant in representing a potential hazard for the patient when participating in this study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01337011

Contacts
Contact: Kathrin Herz 0049-(0)40-181885 ext 3034 k.herz@asklepios.com

Locations
Germany
ASKLEPIOS Klinik St. Georg Recruiting
Hamburg, Germany, 20099
Contact: Martin Bergmann, PD Dr.    0049(0)40-181885 ext 2308    mar.bergmann@asklepios.com   
Sponsors and Collaborators
Asklepios proresearch
Miltenyi Biotec GmbH
Investigators
Principal Investigator: Martin Bergmann, PD Dr. Asklepios Kliniken Hamburg GmbH
  More Information

No publications provided

Responsible Party: Cornelia Wolf, ASKLEPIOS proresearch
ClinicalTrials.gov Identifier: NCT01337011     History of Changes
Other Study ID Numbers: 1884, 2009-013103-63
Study First Received: April 14, 2011
Last Updated: August 10, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Asklepios proresearch:
Chronic Ischemic Cardiomyopathy

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014