BMAC Enhanced Coronary Artery Bypass Grafting (CABG)

June 25, 2014 updated by: Harvest Technologies

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Haryana
      • Gurgaon, Haryana, India, 122 001
        • Medanta The Medicity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CABG plus BMAC Injection
Injection of Bone Marrow Aspirate Concentrate (BMAC) into ischemic myocardium following CABG during the same open procedure
Device: Harvest SmartPReP2 BMAC System
Injection of 10, 15, or 20 cc of BMAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in left ventricular function
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvest Technologies

Investigators

  • Principal Investigator: Naresh Trehan, MD, Medanta-The Medicity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

December 16, 2009

First Submitted That Met QC Criteria

February 2, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congestive Heart Failure

Clinical Trials on Harvest SmartPReP2 BMAC System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe