BMAC Enhanced Coronary Artery Bypass Grafting (CABG)

Phase 1

Terminated

• Conditions: Congestive Heart Failure
• Interventions: Device: Harvest SmartPReP2 BMAC System

• Registration Number: NCT01061580
• Lead Sponsor: Harvest Technologies

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.

Study Timeline

• Study First Submitted: 2009-12-16
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Study Start: 2010-05
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be enrolled in the trial:

• 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

Subjects will be excluded if they meet any of the 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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CABG plus BMAC Injection	Harvest SmartPReP2 BMAC System	Injection of Bone Marrow Aspirate Concentrate (BMAC) into ischemic myocardium following CABG during the same open procedure

Primary Outcome Measures

Name	Time	Method
Changes in left ventricular function	12 months

Secondary Outcome Measures

Name	Time	Method
QOL (Rand 36; Minnesota Living with Heart Failure Questionnaire)	12 months
NYHA or CCS classification evaluation	12 months
Changes in left ventricular ejection fraction	12 months
Changes in left ventricular end-diastolic volume	12 months
Safety	12 months

Trial Locations

Locations (1)

Medanta The Medicity; 🇮🇳 Gurgaon, Haryana, India