BMAC Enhanced Coronary Artery Bypass Grafting (CABG)

NCT ID: NCT01061580

Last Updated: 2014-06-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-12-31

Brief Summary

Injection of concentrated bone marrow cells into the myocardium during CABG procedure.

Detailed Description

Injection of autologous concentrated bone marrow cells into the myocardium during CABG procedure.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CABG plus BMAC Injection

Injection of Bone Marrow Aspirate Concentrate (BMAC) into ischemic myocardium following CABG during the same open procedure

Group Type: EXPERIMENTAL

Harvest SmartPReP2 BMAC System

Intervention Type: DEVICE

Injection of 10, 15, or 20 cc of BMAC

Interventions

Harvest SmartPReP2 BMAC System

Injection of 10, 15, or 20 cc of BMAC

Intervention Type: DEVICE

Eligibility 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, Hemocult 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%

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harvest Technologies

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Naresh Trehan, MD

Role: PRINCIPAL_INVESTIGATOR

Medanta-The Medicity

Locations

Medanta The Medicity

Gurgaon, Haryana, India

Countries

India

Other Identifiers

2009-1

Identifier Type: -

Identifier Source: org_study_id