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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014