Feasibility Study of BMAC Enhanced CABG

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: NCT01074099
Recruitment Status : Terminated (Pilot results in change to protocol, new study needed.)
First Posted : February 24, 2010
Results First Posted : January 18, 2016
Last Update Posted : January 18, 2016
University of Utah
Information provided by (Responsible Party):
Harvest Technologies

Brief Summary:
Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Biological: BMAC Procedure: CABG only Phase 1 Phase 2

Detailed Description:
Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium. Control subjects will undergo CABG only

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Feasibility Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting(CABG) Surgery
Study Start Date : February 2011
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Control
CABG only
Procedure: CABG only
Control subjects will undergo CABG surgery without BMAC injection
Experimental: BMAC enhanced CABG
Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery
Biological: BMAC
Injection of BMAC into ischemic myocardium during CABG

Primary Outcome Measures :
  1. Change in Cardiac Status (Classification) [ Time Frame: Through 12 months post treatment ]
    A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation

  2. Safety [ Time Frame: through 1 Year post tx ]
    as measured by frequency and severity of adverse events

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age> 18 years and ability to understand the planned treatment.
  • Patients with ischemic congestive heart failure requiring by pass surgery
  • Congestive heart failure with ejection fraction ≤ 40%.
  • Serum bilirubin, SGOT and SGPT ≤2.5 time the upper level of normal.
  • Serum creatinine < 3.0 or no dialysis.
  • NYHA performance status ≥ 3.
  • Negative pregnancy test (in women with childbearing potential).
  • Subject has read and signed the IRB approved Informed Consent form
  • Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000, Creatinine ≤ 3.0 mg / Dl, and/or no dialysis, INR ≤ 1.6 unless on Coumadin, or PTT <1.5 x control (to avoid bleeding complications) Patients on Coumadin will be corrected prior to the procedure and must have an INR<1.6 at the time of randomization/surgery

Exclusion Criteria:

  • Female who is pregnant or nursing, or of child bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study.
  • History of Prior Radiation Exposure for oncological treatment.
  • History of Bone Marrow Disorder (especially NHL, MDS) that prohibit transplantation.
  • History of abnormal Bleeding or Clotting.
  • History of Liver Cirrhosis.
  • Acute Myocardial Infarction < 4 weeks from treatment date.
  • Known active malignancy or results outside of normal limits from the following tests: PAP, Chest X-ray, PSA, Mammogram, Hemoccult unless follow-up studies reveal patient to be cancer free.
  • Active clinical infection being treated by antibiotics within one week of enrollment
  • Terminal renal failure with existing dependence on dialysis
  • Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
  • Unable to have 250cc bone marrow harvested.
  • Medical risk that precludes anesthesia or ASA Class 5
  • History of ventricular arrhythmia if AICD is not present.
  • History of ventricular aneurysm.
  • Concurrent surgery such as CABG with valve surgery.
  • Minimally Invasive bypass surgery
  • Life expectancy <6 months due to concomitant illnesses
  • Treatment with immunosuppressant drugs (including Prednisone > 5 mg per day)
  • Patients undergoing urgent by pass surgical procedure
  • Patients with HGB A1C > 8.5%

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): NCT01074099

United States, Texas
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Harvest Technologies
University of Utah
Principal Investigator: Amit Patel, MD University of Utah

Responsible Party: Harvest Technologies Identifier: NCT01074099     History of Changes
Other Study ID Numbers: Harvest 2009-1
First Posted: February 24, 2010    Key Record Dates
Results First Posted: January 18, 2016
Last Update Posted: January 18, 2016
Last Verified: August 2014

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases