NCT01074099TerminatedPhase 1
Feasibility Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting(CABG) Surgery
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Harvest Technologies
- Enrollment
- 5
- Locations
- 4
- Primary Endpoint
- Change in Cardiac Status (Classification)
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 ≥
- •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%
Outcomes
Primary Outcomes
Change in Cardiac Status (Classification)
Time Frame: Through 12 months post treatment
A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation
Safety
Time Frame: through 1 Year post tx
as measured by frequency and severity of adverse events
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
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