search
Back to results

Feasibility Study of BMAC Enhanced CABG

Primary Purpose

Congestive Heart Failure

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BMAC
CABG only
Sponsored by
Harvest Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

  • 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, Hemoccult 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%

Sites / Locations

  • The Methodist Hospital
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

BMAC enhanced CABG

Arm Description

CABG only

Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery

Outcomes

Primary Outcome Measures

Change in Cardiac Status (Classification)
A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation
Safety
as measured by frequency and severity of adverse events

Secondary Outcome Measures

Full Information

First Posted
February 1, 2010
Last Updated
December 14, 2015
Sponsor
Harvest Technologies
Collaborators
University of Utah
search

1. Study Identification

Unique Protocol Identification Number
NCT01074099
Brief Title
Feasibility Study of BMAC Enhanced CABG
Official Title
Feasibility Study of Autologous Concentrated Bone Marrow Nucleated Cell Therapy for Congestive Heart Failure Patients Undergoing Treatment With Coronary Artery Bypass Grafting(CABG) Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
Pilot results in change to protocol, new study needed.
Study Start Date
February 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Harvest Technologies
Collaborators
University of Utah

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium
Detailed Description
Patients undergoing CABG will have 60 mL of bone marrow drawn, concentrated in a SmartPRep2 centrifuge and have the concentrated nucleated cells injected into areas of ischemic myocardium. Control subjects will undergo CABG only

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
CABG only
Arm Title
BMAC enhanced CABG
Arm Type
Experimental
Arm Description
Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery
Intervention Type
Biological
Intervention Name(s)
BMAC
Intervention Description
Injection of BMAC into ischemic myocardium during CABG
Intervention Type
Procedure
Intervention Name(s)
CABG only
Intervention Description
Control subjects will undergo CABG surgery without BMAC injection
Primary Outcome Measure Information:
Title
Change in Cardiac Status (Classification)
Description
A change in cardiac status as determined by the New York Heart Association (NYHA) or Canadian Cardiovascular Society (CCS) classification evaluation
Time Frame
Through 12 months post treatment
Title
Safety
Description
as measured by frequency and severity of adverse events
Time Frame
through 1 Year post tx

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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, Hemoccult 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Patel, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Feasibility Study of BMAC Enhanced CABG

We'll reach out to this number within 24 hrs