Feasibility Study of BMAC Enhanced CABG

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01074099
• Other study ID #: Harvest 2009-1
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: February 1, 2010
• Last updated: December 14, 2015
• Start date: February 2011
• Est. completion date: April 2013

Study information

• Verified date: August 2014
• Source: Harvest Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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%

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Biological:
• BMAC
Injection of BMAC into ischemic myocardium during CABG

Procedure:
• CABG only
Control subjects will undergo CABG surgery without BMAC injection

Locations

Country	Name	City	State
United States	The Methodist Hospital	Houston	Texas
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Harvest Technologies	University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through 12 months post treatment	No
Primary	Safety	as measured by frequency and severity of adverse events	through 1 Year post tx	Yes