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

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ClinicalTrials.gov Identifier: NCT01337011
Recruitment Status : Terminated (study was stopped due to funding issues)
First Posted : April 18, 2011
Last Update Posted : March 27, 2018
Sponsor:
Collaborator:
Miltenyi Biomedicine GmbH
Information provided by (Responsible Party):
Dr. Kai Jaquet, Asklepios proresearch

Tracking Information
First Submitted Date  ICMJE April 14, 2011
First Posted Date  ICMJE April 18, 2011
Last Update Posted Date March 27, 2018
Actual Study Start Date  ICMJE July 2011
Actual Primary Completion Date March 2, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
Change in Left Ventricular Global Ejection Fraction measured via echocardiography [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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%.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-coronary Versus Intramyocardial Application of Enriched CD133pos Autologous Bone Marrow Derived Stem Cells
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Comparison of the effect of CD133pos. bone marrow derived stem cells using the intra-myocardial vs. the intra-coronary route of administration for improving left ventricular function in patients with chronic ischemic cardiomopathy.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: intra-coronary administration
    Application of stem cells using the intra-coronary route.
    Intervention: Other: autologous CD133pos stem cell application
  • Experimental: intra-myocardial administration
    Application of stem cells using the intra-myocardial route.
    Intervention: Other: autologous CD133pos stem cell application
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 23, 2018)
10
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2011)
64
Actual Study Completion Date  ICMJE July 17, 2017
Actual Primary Completion Date March 2, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01337011
Other Study ID Numbers  ICMJE 1884
2009-013103-63 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Dr. Kai Jaquet, Asklepios proresearch
Study Sponsor  ICMJE Dr. Kai Jaquet
Collaborators  ICMJE Miltenyi Biomedicine GmbH
Investigators  ICMJE
Principal Investigator: Martin Bergmann, PD Dr. Asklepios Kliniken Hamburg GmbH
PRS Account Asklepios proresearch
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP