BMAC Enhanced Coronary Artery Bypass Grafting (CABG)

NCT01061580 | Terminated Phase 1

• 1 other identifier: 2009-1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Congestive Heart Failure

Keywords

Bone Marrow Concentrate; CABG; Cardiac; Stem Cell

Outcome Measures

Primary Outcomes (1)

• Changes in left ventricular function

  12 months

Secondary Outcomes (5)

• 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

Study Arms (1)

CABG plus BMAC Injection

EXPERIMENTAL

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

Device: Harvest SmartPReP2 BMAC System

Interventions

Harvest SmartPReP2 BMAC System DEVICE

Injection of 10, 15, or 20 cc of BMAC

CABG plus BMAC Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvest Technologies: lead

Study Sites (1)

Medanta The Medicity

Gurgaon, Haryana, 122 001, India

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Naresh Trehan, MD

  Medanta-The Medicity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: February 3, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

IN (1)