Clinical trial NCT01061580: BMAC Enhanced Coronary Artery Bypass Grafting (CABG)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Congestive Heart Failure
Keywords: Bone Marrow Concentrate
CABG
Cardiac
Stem Cell
Lead sponsor: Harvest Technologies
Sponsor class: INDUSTRY
First posted: 2010-02-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Eligibility 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%

Primary outcomes:
measure: Changes in left ventricular function
timeFrame: 12 months
Secondary outcomes:
measure: QOL (Rand 36; Minnesota Living with Heart Failure Questionnaire)
timeFrame: 12 months
measure: NYHA or CCS classification evaluation
timeFrame: 12 months
measure: Changes in left ventricular ejection fraction
timeFrame: 12 months
measure: Changes in left ventricular end-diastolic volume
timeFrame: 12 months
measure: Safety
timeFrame: 12 months
Other outcomes:
Locations:
city: Gurgaon
country: India
facility: Medanta The Medicity
state: Haryana
Study officials:
affiliation: Medanta-The Medicity
name: Naresh Trehan, MD
role: PRINCIPAL_INVESTIGATOR
References: