Feasibility Study of BMAC Enhanced CABG

Feasibility Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting(CABG) Surgery

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

Study Overview

• Status: Terminated
• Conditions: Congestive Heart Failure
• Intervention / Treatment: Procedure: CABG only; Biological: BMAC

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
• Enrollment (Actual): 5
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cardiac Status (Classification)	A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation	Through 12 months post treatment
Safety	as measured by frequency and severity of adverse events	through 1 Year post tx

Collaborators and Investigators

• Sponsor: Harvest Technologies
• Collaborators: University of Utah

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: February 1, 2010
• First Submitted That Met QC Criteria: February 22, 2010
• First Posted (Estimate): February 24, 2010

Study Record Updates

• Last Update Posted (Estimate): January 18, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Harvest 2009-1