Congestive Heart Failure
Conditions
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
Interventions
BIOLOGICALBMAC
Injection of BMAC into ischemic myocardium during CABG
PROCEDURECABG only
Control subjects will undergo CABG surgery without BMAC injection
Sponsors
University of Utah
Harvest Technologies
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 ≥ 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%
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiac Status (Classification) | 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 | through 1 Year post tx | as measured by frequency and severity of adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control CABG only
CABG only: Control subjects will undergo CABG surgery without BMAC injection | 2 |
| BMAC Enhanced CABG Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery
BMAC: Injection of BMAC into ischemic myocardium during CABG | 3 |
| Total | 5 |
Baseline characteristics
| Characteristic | Control | BMAC Enhanced CABG | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Region of Enrollment United States | 2 participants | 3 participants | 5 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 2 | 1 / 3 |
Outcome results
Primary
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
Time frame: Through 12 months post treatment
Population: Study was terminated after enrollment of only 5 patients. The data were not analyzed for efficacy.
Primary
Safety
as measured by frequency and severity of adverse events
Time frame: through 1 Year post tx
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Safety | 0 participants |
| BMAC Enhanced CABG | Safety | 0 participants |