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:
Asklepios proresearch
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
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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 May 16, 2013