BMAC Enhanced Coronary Artery Bypass Grafting (CABG)

Dose Response Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting (CABG) Surgery

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01061580

Enrollment

Registered

2010-02-03

Start date

2010-05-31

Completion date

2013-12-31

Last updated

2014-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

Bone Marrow Concentrate, CABG, Cardiac, Stem Cell

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.

Interventions

DEVICEHarvest SmartPReP2 BMAC System

Injection of 10, 15, or 20 cc of BMAC

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes in left ventricular function	12 months

Secondary

Measure	Time frame
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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026