Feasibility Study of BMAC Enhanced CABG
This study has been terminated.
(Pilot results in change to protocol, new study needed.)
Sponsor:
Harvest Technologies
Collaborator:
University of Utah
Information provided by (Responsible Party):
Harvest Technologies
ClinicalTrials.gov Identifier:
NCT01074099
First received: February 1, 2010
Last updated: April 11, 2013
Last verified: April 2013
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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 |
| Estimated Study Completion Date: | April 2013 |
| Estimated 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
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: | April 11, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 23, 2013