BMAC Enhanced Coronary Artery Bypass Grafting (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: NCT01061580
Recruitment Status : Terminated
First Posted : February 3, 2010
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):
Harvest Technologies

Brief Summary:
Injection of concentrated bone marrow cells into the myocardium during CABG procedure.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Device: Harvest SmartPReP2 BMAC System Phase 1 Phase 2

Detailed Description:
Injection of autologous concentrated bone marrow cells into the myocardium during CABG procedure.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Response 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 : May 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CABG plus BMAC Injection
Injection of Bone Marrow Aspirate Concentrate (BMAC) into ischemic myocardium following CABG during the same open procedure
Device: Harvest SmartPReP2 BMAC System
Injection of 10, 15, or 20 cc of BMAC

Primary Outcome Measures :
  1. Changes in left ventricular function [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. QOL (Rand 36; Minnesota Living with Heart Failure Questionnaire) [ Time Frame: 12 months ]
  2. NYHA or CCS classification evaluation [ Time Frame: 12 months ]
  3. Changes in left ventricular ejection fraction [ Time Frame: 12 months ]
  4. Changes in left ventricular end-diastolic volume [ Time Frame: 12 months ]
  5. Safety [ Time Frame: 12 months ]

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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:

Subjects must meet all of the following inclusion criteria to be enrolled in the trial:

  • 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:

Subjects will be excluded if they meet any of the 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, Hemocult 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): NCT01061580

Medanta The Medicity
Gurgaon, Haryana, India, 122 001
Sponsors and Collaborators
Harvest Technologies
Principal Investigator: Naresh Trehan, MD Medanta-The Medicity

Responsible Party: Harvest Technologies Identifier: NCT01061580     History of Changes
Other Study ID Numbers: 2009-1
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by Harvest Technologies:
Bone Marrow Concentrate
Stem Cell

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases