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Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement (ASSURANCE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00869024
First received: March 24, 2009
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine if the delivery of cells just after implantation of left ventricular assist device will help to improve the pumping function of your heart and minimize heart enlargement in the future.

The cells will be obtained by aspiration or withdrawal of fluid from your bone marrow from your pelvic bone using a needle and syringe. This would not take place until 24-48 hours prior to your planned left ventricular assist device implantation. During the surgery the surgeons will inject the prepared cells that were taken from your bone marrow and inject it into your heart muscle.

This study will test whether receiving your own bone marrow cells directly into your heart will help your heart to recover function after placement of a left ventricular assist device.


Condition Intervention Phase
Heart Failure
Biological: Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AsseSsment of Efficacy, Safety and Utility of intRa myocardiAl iNjection of Stem Cells in Patients With End Stage Heart Failure Undergoing LVAD Implantation (ASSURANCE)

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Safety of cell delivery [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Improvement in myocardial viability by PET/CT scan [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Combined end points of death and re-hospitalization [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemodynamic parameters at baseline and with weaning of LVAD [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Reduction in left ventricular dimensions [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Histological assessment: [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: November 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem Cell therapy
Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells in Patients with Severe LV Dysfunction and LVAD Support
Biological: Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells
Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit).

Detailed Description:

Patients who meet the inclusion and exclusion criteria and agree to participate will be enrolled in the study. All the patients will have a baseline EKG, Laboratory tests, 2D ECHO and PET/CT imaging.Day prior to the LVAD implantation all the patients will undergo bone marrow aspiration. Bone marrow aspirate will be processed according to the protocols used by that facility. After processing, the bone marrow mononuclear cells will then be suspended in 2ml of 5% human serum albumin and labeled per the standard protocol of the facility.

Patients will be randomized in a 2:1 fashion either to receive cells or 5% serum albumin. Under general anesthesia using the standard techniques the HeartMate II (LVAD) will be placed. The LVAD will be inserted into the LV apex (with removal of 2 x 2 cm ventricular core). The tissue core will be processed for RNA isolation and morphological analysis. CV surgeon will inject either the cells or placebo directly in to the myocardium in the LAD territory. Ten separate injections will be delivered into the LV free wall (20 X 106 cells / 400 micro lit). The injection sites will be marked with Titanium surgical clips. Subjects will be managed at all times by the current standard of care in this hospital for the patients with an LVAD. Routine postoperative care procedures will be followed with close follow-up for dysrrhythmias or signs of infection.

Tissue sample from the core of the left ventricular apex removed at the time of implantation of LVAD will be compared with the myocardium (marked with the surgical clips) from the explanted heart at the time of transplantation. These samples from the experimental subjects and control hearts will be examined for morphology for interstitial fibrosis, hypertrophy, myocyte diameter and myocytolysis as well as for gene expression using RT-PCR.

Research-related follow-up will take place at weeks 2, 4, 6, 8 and months 6, 12, 18 and 24 after LVAD implant at the Clinical Trial Center of the Cardiology Division at the University of Minnesota. Patients will be examined by the PI or Sub-I at each visit. Follow up data to be obtained at these clinic visits is outlined in the protocol

  Eligibility

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

Inclusion Criteria:

  1. Severe LV dysfunction with EF < 30% with cardiomyopathy ( Ischemic and non ischemic)
  2. NYHA Class III and IV
  3. No revascularization options available
  4. LVAD placement as destination therapy or bridging to transplantation
  5. Age between 18-80 years

Exclusion Criteria:

  1. History of recent malignancy( less than one year) .
  2. Unstable hemodynamics at the time of the implant; defined by need for increasing vasopressor medication in the last 24 hours or blood pressure < 70 systolic, or cardiac index < 1.3 liters/min.
  3. Coronary anatomy suitable for revascularization at the time of surgery
  4. Pregnancy confirmed by positive urine test
  5. Lactating mothers
  6. Renal failure with serum creatinine >3.0, or are receiving chronic dialysis support.
  7. Inability to undergo PET/CT imaging.
  8. A history of any significant recent bleeding disorder or coagulation profile of concern for acute bleeding, such as INR >2.0 (not on anticoagulant), platelet count <100,000, or hemoglobin <8.0 gr/dl.
  9. Patients with known infectious disease (Hepatitis, HIV) etc.
  10. Patients with three times or more of the upper limits of normal enzymes.

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  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: NCT00869024

Contacts
Contact: Barbara Brun-Ding, BSN, RN. 612 625 5949 bruhn028@umn.edu
Contact: Emily C Caldwell, BSN, RN. 612 626 3656 Caldw076@umn.edu

Locations
United States, Minnesota
University Of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Ganesh Raveendran, MD    612-625-7924    ravee001@umn.edu   
Contact: Emily Caldwell, BSN, RN.    612 626 3656    caldw076@umn.edu   
Sub-Investigator: Cindy Martin, MD         
Sub-Investigator: Ranjit John, MD         
Sub-Investigator: David McKenna, MD         
Sub-Investigator: Daniel Garry, MD, Ph.D         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Ganesh Raveendran, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00869024     History of Changes
Other Study ID Numbers: pending
Study First Received: March 24, 2009
Last Updated: June 21, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Heart failure
Left ventricular assist device
Stem cells

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014