Feasibility Study of BMAC Enhanced CABG

This study has been terminated.
(Pilot results in change to protocol, new study needed.)
Sponsor:
Collaborator:
University of Utah
Information provided by (Responsible Party):
Harvest Technologies
ClinicalTrials.gov Identifier:
NCT01074099
First received: February 1, 2010
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Congestive Heart Failure
Biological: BMAC
Procedure: CABG only
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Harvest Technologies:

Primary Outcome Measures:
  • change in cardiac status (classification) [ Time Frame: through 12 months post tx ] [ Designated as safety issue: No ]
    • NYHA or CCS classification evaluation


Secondary Outcome Measures:
  • Safety [ Time Frame: through 1 Year post tx ] [ Designated as safety issue: Yes ]
    as measured by frequency and severity of adverse events


Enrollment: 3
Study Start Date: February 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  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: NCT01074099

Locations
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
Investigators
Principal Investigator: Amit Patel, MD University of Utah
  More Information

No publications provided

Responsible Party: Harvest Technologies
ClinicalTrials.gov Identifier: NCT01074099     History of Changes
Other Study ID Numbers: Harvest 2009-1
Study First Received: February 1, 2010
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014