BMAC Enhanced Coronary Artery Bypass Grafting (CABG)

Congestive Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01061580
• Other study ID #: 2009-1
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: December 16, 2009
• Last updated: June 25, 2014
• Start date: May 2010
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: Harvest Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Harvest SmartPReP2 BMAC System
Injection of 10, 15, or 20 cc of BMAC

Locations

Country	Name	City	State
India	Medanta The Medicity	Gurgaon	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Harvest Technologies

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in left ventricular function		12 months	No
Secondary	QOL (Rand 36; Minnesota Living with Heart Failure Questionnaire)		12 months	Yes
Secondary	NYHA or CCS classification evaluation		12 months	Yes
Secondary	Changes in left ventricular ejection fraction		12 months	Yes
Secondary	Changes in left ventricular end-diastolic volume		12 months	Yes
Secondary	Safety		12 months	Yes