Safety Study of Transmyocardial Revascularization (TMR) With Bone Marrow Aspirate (BMAC) for Angina Reduction (PHOENIX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285297
Recruitment Status : Terminated
First Posted : January 28, 2011
Last Update Posted : August 19, 2015
Information provided by (Responsible Party):
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.

Brief Summary:
The purpose of this study is to determine the safety of injecting autologous bone marrow concentrate with laser transmyocardial revascularization (TMR) for treatment of angina which cannot be treated by direct coronary intervention.

Condition or disease Intervention/treatment Phase
Angina Biological: Bone Marrow Aspirate Concentrate Not Applicable

Detailed Description:
Recently published information suggests the delivery of concentrated autologous bone marrow, in combination with transmyocardial revascularization (TMR) may provide synergistic effects for the reduction of angina in patients who are not treatable with conventional coronary artery bypass or percutaneous coronary intervention. This safety and feasibility study is intended to confirm the work previously done at one hospital in a larger, multicenter setting. Patients who are candidates for TMR will be asked to participate.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Single Arm Study of Transmyocardial Revascularization (TMR) Plus Bone Marrow Aspirate Concentrated (BMAC) Using the Cardiogenesis PHOENIX Combination Handpiece Delivery System
Study Start Date : October 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Experimental: TMR plus BMAC injection
Injection of bone marrow aspirate concentrate into reversibly ischemic myocardium with transmyocardial revascularization during the same open procedure.
Biological: Bone Marrow Aspirate Concentrate
Injection of up to 18 mL BMAC

Primary Outcome Measures :
  1. Major adverse cardiac and cerebral events (MACCE) [ Time Frame: One Year ]
    MACCE is defined as cardiac death, cerebrovascular accidents, myocardial infarction, serious arrhythmia and congestive heart failure

  2. Mortality [ Time Frame: One Year ]
    All cause mortality

Secondary Outcome Measures :
  1. Exercise Tolerance Test [ Time Frame: 3, 6 and 12 months ]
    Exercise tolerance to onset of moderately severe angina

  2. Ejection Fraction [ Time Frame: 6 and 12 months ]
    Ejection fraction and areas of myocardial ischemia by cardiac MRI

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patient, 18 years of age or older, male or female.
  • Left ventricular ejection fraction greater than or equal to 40% (documented within 6 months of the TMR procedure.
  • Patient with medically refractory, stable, Class IV angina according to the Canadian Cardiovascular Society angina scale. Optimal medical therapy is defined as maximum tolerable and stable doses of beta-blockers, statins, anti-platelets and long acting nitrates without control of symptoms for at least 30 days.
  • Patient with at least a 15 cm² (or 15% of the surface area in the distal 2/3 of the left ventricle free wall to allow for a minimum of 15 TMR channels) documented region of the myocardium in the distal two-thirds of the left ventricle with reversible ischemia. Patients will be enrolled based on images used to determine eligibility for TMR within the previous 6 months. However, all patients will have baseline and follow-up MRIs taken per a standardized protocol and adjudicated by a core lab.
  • Has a documented left ventricular wall thickness of ≥8 mm.
  • Patient is not a candidate for treatment by direct coronary revascularization methods (i.e., CABG or PCI) as documented by an independent interventional cardiologist and an independent cardiothoracic surgeon on the Angiographic Screening Form.
  • Patient is able to perform the baseline exercise tolerance test (ETT).
  • Patient, if female, has no childbearing potential or has had a negative urine or serum pregnancy test within 7 days of the procedure.
  • Patient has a bone marrow aspirate total nucleated count of at least 15 x 106/mL at the time of harvest.
  • Patient has provided informed consent.

Exclusion Criteria:

  • Cannot undergo a surgical procedure, thoracotomy or general anesthesia.
  • Has any mechanical or prosthetic heart valve.
  • Has a history of bone marrow disease (especially Non-Hodgkin's Lymphoma and Myelodysplastic Syndrome) that prohibits autologous bone marrow derived cell transplantation.
  • Has severe, new onset or increasing angina. In addition, patients who cannot be weaned from intravenous anti-anginal medications for at least 48 hours preoperatively are to be excluded. Severe, new onset and increasing angina is defined as: Severe angina - angina occurring at rest and usually prolonged >20 minutes occurring within a week of presentation; new onset angina - angina of at least Canadian Cardiovascular Society Classification (CCSC) III severity with onset within 2 months of initial presentation; and increasing angina - previously diagnosed angina that is distinctly more frequent, longer in duration, or lower in threshold, (i.e., increased by at least one CCSC class within 2 months of initial presentation to at least CCSC III severity.
  • Has had a STEMI (ST Elevation Myocardial Infarction) or NSTEMI (Non-STEMI) within 4 weeks of the TMR procedure.
  • Has decompensated heart failure, or a diagnosis of NYHA Functional Class III/IV heart failure.
  • Has a hemorrhagic propensity that cannot be addressed with drug management.
  • Has severe or life-threatening arrhythmia (e.g., ventricular tachycardia or fibrillation) within one week prior to the TMR procedure.
  • Is unable to undergo a cardiac MRI procedure.
  • Has uncontrolled diabetes with HbA1C > 10%.
  • Has anemia defined as hematocrit < 33% in women and <39% in men.
  • Has moderate to severe renal dysfunction defined as serum creatinine >1.8 mg/dL.
  • Has moderate to severe liver dysfunction defined as> ALT/AST >5X the upper limit of normal.
  • Is unable or unwilling to return for follow-up.
  • Is participating in another clinical investigation within the prior 30 days.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01285297

Russian Federation
Bakoulev Scientific Center for Cardio-vascular Surgery
Moscow, Russian Federation, 121552
Hospital Universitario de La Princesa
Madrid, Spain, 28006
Sponsors and Collaborators
Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.
Study Director: Keith B Allen, MD Clinical Advisor

Responsible Party: Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc. Identifier: NCT01285297     History of Changes
Other Study ID Numbers: PHX 09-003
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

Keywords provided by Cardiogenesis Corporation, a wholly-owned subsidiary of CryoLife, Inc.:
Transmyocardial revascularization (TMR)
Bone marrow aspirate concentrate (BMAC)

Additional relevant MeSH terms:
Angina Pectoris
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Signs and Symptoms