BMAC Enhanced Coronary Artery Bypass Grafting (CABG)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Harvest Technologies
ClinicalTrials.gov Identifier:
NCT01061580
First received: December 16, 2009
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Congestive Heart Failure
Device: Harvest SmartPReP2 BMAC System
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Harvest Technologies:

Primary Outcome Measures:
  • Changes in left ventricular function [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • QOL (Rand 36; Minnesota Living with Heart Failure Questionnaire) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • NYHA or CCS classification evaluation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Changes in left ventricular ejection fraction [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Changes in left ventricular end-diastolic volume [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: May 2010
Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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%
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061580

Locations
India
Medanta The Medicity
Gurgaon, Haryana, India, 122 001
Sponsors and Collaborators
Harvest Technologies
Investigators
Principal Investigator: Naresh Trehan, MD Medanta-The Medicity
  More Information

No publications provided

Responsible Party: Harvest Technologies
ClinicalTrials.gov Identifier: NCT01061580     History of Changes
Other Study ID Numbers: 2009-1
Study First Received: December 16, 2009
Last Updated: June 25, 2014
Health Authority: India: Drugs Controller General of India

Keywords provided by Harvest Technologies:
Bone Marrow Concentrate
CABG
Cardiac
Stem Cell

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 21, 2014