Trial record 9 of 204 for:    Open Studies | coronary artery bypass

IMPACT-CABG Trial: IMPlantation of Autologous CD133+ sTem Cells in Patients Undergoing Coronary Artery Bypass Grafting

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Miltenyi Biotec, Inc.
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01467232
First received: October 28, 2011
Last updated: November 7, 2011
Last verified: October 2011
  Purpose

Following myocardial infarct, cellular therapy is a potential approach to repopulate the injured myocardium, to treat heart failure and restore cardiac function. The purpose of this study is to assess the safety, feasibility and efficacy of intramyocardial delivery of selected autologous CD133+ bone marrow stem cells at the time of coronary artery bypass grafting in patients with chronic ischemic cardiomyopathy.


Condition Intervention Phase
Heart Failure
Heart Attack
Coronary Artery Bypass Surgery
Biological: Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implantation of Autologous CD133+ Stem Cells in Patients Undergoing CABG

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Freedom from Major Adverse Cardiac Event [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    cardiac death, myocardial infarct, repeat coronary bypass grafting or percutaneous intervention of bypassed artery.

  • Freedom from major arrhythmia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    sustained ventricular tachycardia or survived sudden death.


Secondary Outcome Measures:
  • Regional myocardial perfusion and function assessed by magnetic resonance scans [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Global ventricular function assessed by echocardiographic measures of ejection fraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Relief of symptom severity after CABG surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Device performance end point [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Feasibility to produce from 100ml of bone marrow aspiration a final cell product that contains a target CD133+ cells higher than 0.5 million with a purity superior to 30% and a recovery superior to 10%.

  • Quality of Life after CABG surgery [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous CD133+ Stem Cells
Autologous CD133+ stem cells
Biological: Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting
Following completion of the distal coronary artery bypasses, autologous CD133+ stem cells, or placebo (saline solution containing autologous plasma without CD133+) will be injected into the myocardium.
Other Name: Autologous CD133+ stem cells or placebo solution containing autologous plasma without CD133+
Placebo Comparator: Saline solution containing autologous plasma
Saline solution containing autologous plasma without CD133+ (indistinguishable from the autologous CD133+ stem cells)
Biological: Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting
Following completion of the distal coronary artery bypasses, autologous CD133+ stem cells, or placebo (saline solution containing autologous plasma without CD133+) will be injected into the myocardium
Other Name: Autologous CD133+ stem cells or placebo solution containing autologous plasma without CD133+.

Detailed Description:

CD133+ are well characterized distinct early progenitor group of stem cells that possess high engraftment, pluripotent and angiogenic capacity and proved to be valuable for cardiac repair by promoting neovascularization, inhibition of apoptosis and cardiomyogenesis.

The investigators proposed research protocol involves patients with chronic ischemic heart disease and left ventricular dysfunction undergoing coronary artery bypass grafting (CABG). In this phase II clinical trial, prospective, randomized, 2 arm, double-blind, placebo-controlled study, the investigators will assess the safety, feasibility and functional effect of intra-myocardial injection of highly selected autologous CD133+ bone marrow stem cells to placebo.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years, and ≤75 years.
  • Patients with severe chronic ischemic cardiomyopathy manifested by Canadian Cardiovascular Society (CCS) class II or greater angina, and/or New York Heart Association (NYHA) class II or greater dyspnea, AND who have undergone diagnostic coronary angiography demonstrating ≥70% diameter narrowing of at least two major coronary arteries or branches or ≥50% diameter narrowing of the left main coronary artery.
  • Significant left ventricular systolic dysfunction evaluated by echocardiography or LV angiography (LV ejection fraction ≤45% but ≥25%) due to a prior myocardial infarction. This area of left ventricular dysfunction should be akinetic or severely hypokinetic, not dyskinetic or aneurysmal, when assessed by echocardiography or LV angiogram.
  • No contraindications or exclusions (see below).
  • Willingness to participate and ability to provide informed consent.

Exclusion Criteria:

  • contraindications to magnetic resonance imaging (MRI) including presence of an implantable cardiac defibrillator (ICD) or permanent pacemaker (PPM), or cases in which it is anticipated that an ICD or PPM will be implanted prior to the 6 month follow-up or claustrophobia (thus precluding performance of follow-up MRI scans).
  • Need for urgent or emergent revascularization.
  • Anticipated for concomitant surgical procedure at the time of CABG (e.g. valve repair or replacement, aneurysm resection, etc.).
  • Hemodynamically unstable patients, as defined by heart rate ≤40/min or ≥100/min, and/or systolic blood pressure <90 mmHg or ≥200 mmHg, and/or ongoing need for intravenous inotropic or vasopressor medications.
  • Patients with confirmed myocardial infarction within 14 days, and/or rising cardiac biomarker proteins (i.e. CK-MB or troponin), and/or worsening ECG changes.
  • Prior CABG surgery.
  • Stroke within 3 months prior to plan CABG.
  • Immunosuppressive medication (e.g. prednisone, cyclophosphamide, etanercept, etc.)
  • Severe chronic renal insufficiency (serum creatinine ≥ 200 mmol/dl or need for dialysis),liver disease, (diagnosis of cirrhosis, chronic hepatitis, or elevated serum transaminases ≥3 times the upper limit of normal), cerebrovascular disease requiring concomitant carotid endarterectomy, peripheral arterial disease (claudication as the primary factor limiting activity), active non-dermatological malignancy requiring on-going treatment, or any other condition that would place the patient at increased risk for complications during the first 6 months after the procedure in the judgement of the attending cardiologist or cardiac surgeon.
  • Contra-indication to bone marrow aspiration (Thrombocytopenia <50,000 mm3, INR >2.0 ).
  • Hemoglobin less than 10g/dL, white blood cell count less than 4,000/mm3, absolute neutrophil count less than 1500/mm3
  • Active infection, with a temperature greater than 37.5°C within 48 hours prior to surgery and an unexplained white blood cell count in excess of 10,000/mm3
  • Myelodysplastic syndrome
  • Significant cognitive impairment
  • Any condition associated with a life expectancy of less than 6 months
  • Known allergic reaction or contraindication to any of the components of the CD133+ enriched cells
  • Participation in other studies
  • History of severe ventricular tachyarrhythmia's requiring treatment
  • Positive laboratory test results or a history of syphilis, Hepatitis B Virus, Hepatitis C Virus, Human T-Lymphotropic Virus Type 1 and 2, and Human Immunodeficiency Virus.
  • Pregnant woman
  • Inability or unwillingness to provide written informed consent
  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: NCT01467232

Contacts
Contact: Katherine Tsang, BScN, MN, CCRP 416-340-3280 katherine.tsang@uhn.ca

Locations
Canada, Ontario
Peter Munk Cardiac Center/ University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Richard Weisel, MD    416-581-7662    rweisel@uhnres.utoronto.ca   
Principal Investigator: Terrence M Yau, MD, MSc, FRCSC         
Sub-Investigator: Richard Weisel, MD         
Sub-Investigator: Andrew Crean, MD         
Sub-Investigator: Lorretta Daniel, MD         
Sub-Investigator: Diego Delgado, MD         
Sub-Investigator: Armand Keating, MD         
Sub-Investigator: Ren-Ke Li, PhD         
Sub-Investigator: K Nanthakumar, MD         
Sub-Investigator: Narinder Paul, MD         
Sub-Investigator: Heather Ross, MD         
Sub-Investigator: Sowmya Viswanathan, PhD         
Sub-Investigator: Bernd Wintersperger, MD         
Sub-Investigator: Anna Woo, MD         
Sponsors and Collaborators
University Health Network, Toronto
Miltenyi Biotec, Inc.
Investigators
Principal Investigator: Terrence M Yau, MD Peter Munk Cardiac Centre / University Health Network
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01467232     History of Changes
Other Study ID Numbers: UHN-CCR-002
Study First Received: October 28, 2011
Last Updated: November 7, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014