Feasibility Study of BMAC Enhanced CABG

Stopped early · Phase 1/Phase 2

Conditions studied: Congestive Heart Failure

In brief

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

Key facts

Study ID

NCT01074099

Run by

Harvest Technologies

People needed

5

Starts

2011-02-01

Expected to finish

2013-04-01

Last updated by the study team

2016-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

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

Full record on ClinicalTrials.gov

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