Feasibility Study of BMAC Enhanced CABG
This study has been terminated.
(Pilot results in change to protocol, new study needed.)
University of Utah
Information provided by (Responsible Party):
First received: February 1, 2010
Last updated: April 11, 2013
Last verified: April 2013
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
Congestive Heart Failure
Procedure: CABG only
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
||Feasibility Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting(CABG) Surgery
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||April 2013 (Final data collection date for primary outcome measure)
Active Comparator: Control
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
Injection of BMAC into ischemic myocardium during CABG
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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%
Please refer to this study by its ClinicalTrials.gov identifier: NCT01074099
|The Methodist Hospital
|Houston, Texas, United States, 77030 |
|University of Utah
|Salt Lake City, Utah, United States, 84112 |
University of Utah
||Amit Patel, MD
||University of Utah
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 1, 2010
||April 11, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013