Feasibility Study of BMAC Enhanced CABG

NCT01074099 | Terminated Phase 1 Results

• 1 other identifier: Harvest 2009-1
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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

Conditions

Congestive Heart Failure

Outcome Measures

Primary Outcomes (2)

• 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

• Safety

  as measured by frequency and severity of adverse events

  through 1 Year post tx

Study Arms (2)

Control

ACTIVE COMPARATOR

CABG only

Procedure: CABG only

BMAC enhanced CABG

EXPERIMENTAL

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

Biological: BMAC

Interventions

BMAC BIOLOGICAL

Injection of BMAC into ischemic myocardium during CABG

BMAC enhanced CABG

CABG only PROCEDURE

Control subjects will undergo CABG surgery without BMAC injection

Control

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, 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.

Sponsors & Collaborators

• Harvest Technologies: lead
• University of Utah: collaborator

Study Sites (2)

The Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

The study was terminated early. Only 5 subjects were enrolled and they were followed for a year for safety data only. One efficacy data was collected.

Results Point of Contact

• Title: Director of Clinical Operations
• Organization: Harvest Technologies

CLI2011communication@harvesttech.com

508-732-7530

Study Officials

• Amit Patel, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 24, 2010
• Study Start: February 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 18, 2016
• Results First Posted: January 18, 2016

Record last verified: 2014-08

Locations

US (2)